CrawlJobs Logo

Combination Product Quality Specialist Consultant

paconsulting.com Logo

PA Consulting

Location Icon

Location:
United Kingdom , Melbourn

Category Icon

Job Type Icon

Contract Type:
Employment contract

Salary Icon

Salary:

Not provided

Job Description:

We believe in the power of ingenuity to build a positive human future. As strategies, technologies, and innovation collide, we create opportunity from complexity. Our teams of interdisciplinary experts combine innovative thinking and breakthrough technologies to progress further, faster. Our clients adapt and transform, and together we achieve enduring results. We are over 4,000 strategists, innovators, designers, consultants, digital experts, scientists, engineers, and technologists. And we have deep expertise in consumer and manufacturing, defence and security, energy and utilities, financial services, government and public services, health and life sciences, and transport. Our teams operate globally from offices across the UK, Ireland, US, Nordics, and Netherlands. PA. Bringing Ingenuity to Life. Hybrid working - our approach is to be in the office or on client site a minimum of 2 days per week. However, the actual time you spend and where you spend it will vary by role or assignment, including up to 5 days per week on a client site. This role can be based at either our London Victoria or Melbourn office. Within our Life Sciences work, we support global organisations to design, develop and bring to market innovative products that improve patient outcomes. This includes complex combination products across pharmaceuticals, medical devices, biologics and advanced therapies. We are seeking an experienced Combination Product Quality Specialist to support the development and life‑cycle management of combination products (drug–device, biologic–device and advanced therapy–device). You will play a pivotal role in helping our clients navigate regulatory complexity, embed robust quality systems, and ensure product safety, compliance and performance from early development through to post‑market. Working as part of multi‑disciplinary project teams, you will bring deep technical expertise alongside strong collaboration and stakeholder engagement skills.

Job Responsibility:

  • Working within and advising on Quality Management Systems compliant with ISO 13485, QMSR, 21 CFR Part 4 and relevant GxP requirements
  • Authoring, reviewing and maintaining Design History Files, risk management files, technical documentation and change control records, ensuring alignment and traceability across the product life cycle
  • Supporting supplier qualification, audits and gap assessments, ensuring compliance with global regulatory expectations
  • Acting as a subject matter expert on drug‑device interactions and product integrity considerations
  • Interpreting and overseeing Container Closure Integrity Testing (CCIT) to support sterility and product stability
  • Supporting the design and evaluation of stability and compatibility studies, considering both device and pharmaceutical components under real‑world conditions
  • Interpreting and applying evolving global combination product regulations, providing pragmatic guidance throughout development, technical transfer, commercialisation and post‑market phases
  • Supporting the preparation of regulatory submissions, technical dossiers and responses to questions from competent authorities and notified bodies
  • Leading and supporting technology transfer activities across development, scale‑up and commercial manufacturing environments
  • Contributing to process validation, equipment qualification and technical knowledge transfer, ensuring regulatory alignment throughout
  • Leading risk management activities in line with ISO 14971, including hazard analysis, risk evaluation and mitigation strategies
  • Supporting post‑market surveillance, vigilance and complaints investigations, ensuring robust CAPA and documentation
  • Working as part of, or leading, cross‑functional project teams, managing quality deliverables, tracking actions and supporting timely decision‑making

Requirements:

  • Prior management consultancy experience is highly desirable
  • A degree in life sciences, pharmacy, engineering, or a related discipline
  • Significant experience (typically 8+ years) within combination products, pharmaceuticals, medical devices or biotechnology
  • Strong, hands‑on knowledge of quality systems and regulatory frameworks (ISO 13485, 21 CFR Part 4, FDA, EU MDR)
  • Proven experience authoring and maintaining quality and technical documentation in regulated environments
  • A well‑developed understanding of risk management (ISO 14971) and exposure to human factors/usability engineering
  • Experience with supplier quality, audits, CAPA and document control
  • Excellent communication, organisational and project management skills, with the confidence to work with diverse stakeholders
What we offer:
  • Health and lifestyle perks accompanying private healthcare
  • 25 days annual leave (plus a bonus half day on Christmas Eve) with the opportunity to buy 5 additional days
  • Generous company pension scheme
  • Opportunity to get involved with community and charity‑based initiatives
  • Annual performance‑based bonus
  • PA share ownership
  • Tax efficient benefits (cycle to work, give as you earn)

Additional Information:

Job Posted:
April 24, 2026

Employment Type:
Fulltime
Work Type:
Hybrid work
Job Link Share:
PREMIUM
More languages and countries
+ Unlock 31695 hidden job offers
Languages
English Čeština Deutsch Ελληνικά Español Français +15
Countries
United States United Kingdom India Canada Australia +
See plans
Plans from $2.99 / month

Looking for more opportunities? Search for other job offers that match your skills and interests.

Briefcase Icon

Similar Jobs for Combination Product Quality Specialist Consultant

Combination Product Quality Specialist Consultant

We are seeking an experienced Combination Product Quality Specialist to support ...
Location
Location
United Kingdom , London
Salary
Salary:
Not provided
paconsulting.com Logo
PA Consulting
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Prior management consultancy experience is highly desirable
  • A degree in life sciences, pharmacy, engineering, or a related discipline
  • Significant experience (typically 8+ years) within combination products, pharmaceuticals, medical devices or biotechnology
  • Strong, hands‑on knowledge of quality systems and regulatory frameworks (ISO 13485, 21 CFR Part 4, FDA, EU MDR)
  • Proven experience authoring and maintaining quality and technical documentation in regulated environments
  • A well‑developed understanding of risk management (ISO 14971) and exposure to human factors/usability engineering
  • Experience with supplier quality, audits, CAPA and document control
  • Excellent communication, organisational and project management skills, with the confidence to work with diverse stakeholders
Job Responsibility
Job Responsibility
  • Working within and advising on Quality Management Systems compliant with ISO 13485, QMSR, 21 CFR Part 4 and relevant GxP requirements
  • Authoring, reviewing and maintaining Design History Files, risk management files, technical documentation and change control records
  • Supporting supplier qualification, audits and gap assessments
  • Acting as a subject matter expert on drug–device interactions and product integrity considerations
  • Interpreting and overseeing Container Closure Integrity Testing (CCIT)
  • Supporting the design and evaluation of stability and compatibility studies
  • Interpreting and applying evolving global combination product regulations
  • Supporting the preparation of regulatory submissions, technical dossiers and responses
  • Leading and supporting technology transfer activities across development, scale‑up and commercial manufacturing environments
  • Contributing to process validation, equipment qualification and technical knowledge transfer
What we offer
What we offer
  • Health and lifestyle perks accompanying private healthcare
  • 25 days annual leave (plus a bonus half day on Christmas Eve) with the opportunity to buy 5 additional days
  • Generous company pension scheme
  • Opportunity to get involved with community and charity-based initiatives
  • Annual performance-based bonus
  • PA share ownership
  • Tax efficient benefits (cycle to work, give as you earn)
  • Fulltime
Read More
Arrow Right

Storage Sales Specialist

As a Storage Sales Specialist, you will position HPE Storage solutions, expand c...
Location
Location
Germany , Southern Germany
Salary
Salary:
Not provided
https://www.hpe.com/ Logo
Hewlett Packard Enterprise
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Academic degree in business administration or similar
  • +5 years of sales experience with complex IT solutions, especially storage
  • Good knowledge of the storage market
  • Ability to take the sales responsibility for storage opportunities (including Service and aaS )
  • Reliability in building a sales pipeline, forecasting, and customer management (sales excellence)
  • Eagerness to develop a deep knowledge of our storage products and solutions with differentiation from the competition
  • Distinctive customer orientation and consulting skills combined with assertiveness and sales attitude
  • Team and goal-oriented work
  • Creativity, initiative and reliability
  • Negotiation security
Job Responsibility
Job Responsibility
  • Position the HPE Storage product and solution portfolio working on selected local account cross industry in Southern Germany
  • Expand existing and develop new long-term storage customer and strong channel partner relationships
  • Focus on business outcomes for our customers, gladly with the support of our GreenLake Offerings and our Private Cloud and AI portfolio
  • Develop a deep understanding of the end customer's business drivers to implement customer requirements in sustainable HPE business via a comprehensive consulting approach at all levels of the customer
  • Convince customers of the quality and performance of our portfolio as a potential element of their hybrid cloud and digitization strategy
  • Build a well-founded, long-term pipeline for both new and existing storage to increase the HPE Storage share in the German market through their conclusion
  • Lead projects over the entire lifecycle from initial contact, PoCs, preparation and response to tenders, negotiations to the conclusion of the contract as a lead, managing contracts over the lifecycle
  • Work closely with Digital Sales and Sales Support teams as well as with Presales, the GreenLake team, Zerto Sales, the Hybrid Solutions Group and the Storage Category
What we offer
What we offer
  • Competitive salary and extensive benefits package (pension scheme, insurances, company car, bike and car leasing, and other fringe benefits)
  • Work-life balance (flexible working time and hybrid workplace model, 30 vacation days, four HPE Wellness-Fridays, up to six months paid parental leave)
  • Support for education, training, and career development
  • Diverse and dynamic work environment
  • Part-time work or job-sharing is also applicable to this position
  • Fulltime
Read More
Arrow Right

Storage Sales Specialist

Sales Specialist for HPE Storage solutions located in Berlin, Germany. Responsib...
Location
Location
Germany , Berlin
Salary
Salary:
Not provided
https://www.hpe.com/ Logo
Hewlett Packard Enterprise
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Academic degree in business administration or similar
  • +5 years of sales experience with complex IT solutions, especially storage
  • profound knowledge of the storage market
  • ability to take the sales responsibility for storage opportunities (including Service and aaS)
  • reliability in building a sales pipeline, forecasting, and customer management (sales excellence)
  • eagerness to develop a deep knowledge of our storage products and solutions with differentiation from the competition
  • distinctive customer orientation and consulting skills combined with assertiveness and sales attitude
  • team and goal-oriented work
  • creativity, initiative and reliability
  • negotiation security
Job Responsibility
Job Responsibility
  • Position the HPE Storage product and solution portfolio working on selected local account cross industry in Northern Germany
  • expand existing and develop new long-term storage customer and strong channel partner relationships
  • focus on business outcomes for our customers, gladly with the support of our GreenLake Offerings and our Private Cloud and AI portfolio
  • develop a deep understanding of the end customer's business drivers to implement customer requirements in sustainable HPE business via a comprehensive consulting approach at all levels of the customer
  • convince customers of the quality and performance of our portfolio as a potential element of their hybrid cloud and digitization strategy
  • build a well-founded, long-term pipeline for both new and existing storage to increase the HPE Storage share in the German market through their conclusion
  • lead projects over the entire lifecycle from initial contact, PoCs, preparation and response to tenders, negotiations to the conclusion of the contract as a lead, managing contracts over the lifecycle
  • work closely with Digital Sales and Sales Support teams as well as with Presales, the GreenLake team, Zerto Sales, the Hybrid Solutions Group and the Storage Category
What we offer
What we offer
  • Competitive salary and extensive benefits package (pension scheme, insurances, company car, bike and car leasing, and other fringe benefits)
  • work-life balance (flexible working time and hybrid workplace model, 30 vacation days, four HPE Wellness-Fridays, up to six months paid parental leave)
  • support for education, training, and career development
  • diverse and dynamic work environment
  • part-time work or job-sharing also applicable to this position
  • Fulltime
Read More
Arrow Right

Senior Product Specialist, VISIA® CRP

We are seeking a Senior Product Specialist – VISIA‑CRP to play a critical role i...
Location
Location
Salary
Salary:
75000.00 - 95000.00 USD / Year
canfieldsci.com Logo
canfield scientific
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor’s degree or an equivalent combination of education and professional experience
  • 5-10 years demonstrated experience as a product specialist or project manager
  • Exceptional leadership abilities, multitasking between projects as required
  • Proficient with Microsoft Office
  • Ability to switch between technical and non-technical communication methods for end users, customers, or stakeholders
  • Demonstrated ability to work projects, from conception through completion
  • Willingness to travel to conferences and customer sites
Job Responsibility
Job Responsibility
  • Serve as the senior-level expert on VISIA‑CRP across internal teams and external customers including mentoring and supporting new and existing team members
  • Lead advanced product demonstrations, consultative discussions, and solution positioning for enterprise customers, key accounts, and strategic opportunities
  • Provide expert guidance on product capabilities, workflows, and best‑practice use of VISIA‑CRP technology
  • Deliver advanced onboarding and education for customers, including best practices for image capture, analysis, and data interpretation
  • Provide image analysis services to support customers, including review, interpretation, and consultation on VISIA‑CRP imaging data and outputs
  • Translate imaging results and trends into clear, actionable insights that support clinical, research, and business decision‑making
  • Act as a trusted advisor to customers on how to effectively leverage VISIA‑CRP image analysis within their workflows and programs while supporting complex or escalated customer needs
  • Analyze customer usage data, imaging trends, and market feedback to identify strengths, gaps, and opportunities to expand adoption and value
  • Contribute to initiatives that drive revenue growth, differentiate VISIA‑CRP in the market, and improve customer outcomes including identifying opportunities to enhance product positing and services
  • Partner closely with Product Management to inform roadmap decisions related to imaging analytics, reporting, and data‑driven features
What we offer
What we offer
  • paid days off
  • medical, dental, and vision insurance
  • may be eligible for a discretionary bonus
  • 401(k) plan with employer match (currently set at 50%)
  • Fulltime
Read More
Arrow Right

Pharma Quality Specialist Consultant

Our Life Sciences teams work with leading pharmaceutical, biotechnology and heal...
Location
Location
United Kingdom , London
Salary
Salary:
Not provided
paconsulting.com Logo
PA Consulting
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Management Consultancy experience highly desirable
  • A scientific or technical background (life sciences, pharmaceutical sciences, quality or a related discipline)
  • Typically 8+ years’ experience within pharmaceuticals, biotechnology or life sciences, with a strong track record in GxP QMS transformation and implementation
  • Extensive experience drafting and managing quality documentation, including SOPs, standards, policies, forms and templates
  • Strong knowledge of global GxP regulatory frameworks, including FDA, EU GMP/EudraLex, MHRA, EMA and ICH guidance
  • Hands‑on experience with supplier qualification, audits, CAPA and compliance management
  • Experience of RIM and PLM system implementation in regulated environments (highly desirable)
  • Knowledge of computer system validation and data integrity principles
  • Excellent problem‑solving, communication and stakeholder management skills
  • QP status is highly desirable but not essential
Job Responsibility
Job Responsibility
  • QMS design and process transformation
  • Computer system validation and data integrity
  • Supplier quality and audit support
  • Regulatory systems implementation
  • Regulatory and Qualified Person (QP) support
  • Client and stakeholder engagement
What we offer
What we offer
  • Health and lifestyle perks accompanying private healthcare
  • 25 days annual leave (plus a bonus half day on Christmas Eve) with the opportunity to buy 5 additional days
  • Generous company pension scheme
  • Opportunity to get involved with community and charity-based initiatives
  • Annual performance-based bonus
  • PA share ownership
  • Tax efficient benefits (cycle to work, give as you earn)
  • Fulltime
Read More
Arrow Right

Senior Manager Dairy Sanitation

We are looking for an experienced Senior Manager to lead our Dairy Sanitation pr...
Location
Location
United States
Salary
Salary:
100700.00 - 155100.00 USD / Year
cencora.com Logo
Cencora
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Associate’s Degree (A.A.) or equivalent from two-year college or technical school
  • 5 plus years related experience and/or training
  • or equivalent combination of education and experience
  • Must be knowledgeable about all aspects of the dairy industry to include parlors, sanitation, sales, and marketing
  • Understanding of pulsation, milk sensors, and other parlor electronic equipment as well as the sanitation process and how it affects milk quality is required
  • Must have a valid driver’s license
  • Position requires 15-35% travel
  • Core Competencies: Language Skills: Ability to read and interpret documents such as safety rules, operating and maintenance instructions and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of organization
  • Mathematical Skills: Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference and volume. Ability to apply concepts of basic algebra and geometry
  • Reasoning Ability: Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram or schedule form
Job Responsibility
Job Responsibility
  • Milk Quality Program: The milk quality program is a value-based program for creating higher value for the dairy, by focusing on the following system. Pro Control Parlor, Sanitation program and sales, water treatment, and the use of Micro’s proprietary technologies assisting the sanitation service and leading the QA team and coordinating those teams. Continue to develop new technologies. Work with manufacturer partners to ensure price integrity
  • Responsible for working the strategy in developing the Micro Milk Quality Program
  • Manage and oversee the Dairy Sanitation Quality Assurance team as they work with customers to onboard new customers, maintain current customers, diagnose and resolve issues onsite at customer facilities
  • Responsible for hiring, training, ensuring team members are following company guidelines and policies, etc
  • Assist in the search, evaluation and applicability of new profitable Udder Health and C/S products for dairies
  • Provide consultants with information regarding the value and technical benefits of the Micro Milk Quality management program, including Pro Control Blender, Pro Control Parlor, Dairy Chemical Mixer and other technologies as available
  • Focus on the application of Micro’s Milk Quality to different diets and detail the opportunities and flexibilities of utilizing the program to improve performance
  • Collaborate with consulting sanitation specialist in setting up washes with levels through Dairy Chemical Mixer, and Pro Control Parlor
  • Furnish customer/Service team support for Milk Quality program implementation and continued performance
  • Interact with leadership, sales, and operation teams to assist in reaching business growth goals. Present technical information to sales & operation teams to increase Company knowledge of opportunities in dairies
What we offer
What we offer
  • We provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members’ ability to live with purpose every day. In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness. This encompasses support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave. To encourage your personal growth, we also offer a variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more.
  • Fulltime
Read More
Arrow Right

QA Specialist II - Operations

The QA Operations Specialist II – Floor Support is responsible for providing QA ...
Location
Location
United States , Bedford
Salary
Salary:
Not provided
pci.com Logo
PCI Pharma Services
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor’s degree in a relevant scientific field
  • Minimum 3 years’ experience in relevant GMP industry, with minimum 1 year experience in Quality, or Equivalent combination of education and experience
  • ASQ certification is a plus
  • Exposure to RCA, technical writing, and working with quality related investigations
  • Exposure to lean operation excellence highly desirable
  • Knowledge of FDA regulations (i.e., 21CFR Part 210, 211 & 820) and some experience working with international regulations such as ICH
  • Knowledge and ability to apply basic scientific principles to solve operational, as well as routine quality tasks
  • Experience using Risk Management Tools (FMEA, HACCP, PHA, etc.) and familiarity with ICH Q9
Job Responsibility
Job Responsibility
  • Perform QA on-the-floor activities supporting client projects, including room release, auditing critical processes, reviewing GMP documentation in real time, and resolving issues that occur during manufacturing
  • Consult with internal teams such as Operations, QC, Facilities/Engineering, Project Management, and Materials Management to resolve complex situations or problems
  • Perform frequent walkthroughs and internal audits of manufacturing and support areas to ensure adherence to policies and procedures
  • Batch record review for adherence to internal procedures and Good Documentation Practices
  • Support the evaluation and disposition of intermediates, finish bulk drug substance and drug product
  • Review, approval and disposition of incoming materials such as consumables, excipients, and Active Pharmaceutical Ingredient
  • QA review and approval of new and revised GMP documents such as SOP’s and raw material specifications
  • Act as first responder for on the floor quality issues in a timely manner, documentation of all events/investigations and required immediate corrective actions
  • Co-ownership of nonconforming material investigations
  • Review of Quality Control environmental and utility monitoring data and test results
  • Fulltime
Read More
Arrow Right

Leave Of Absence Specialist

This position reviews, assesses and processes exception time for employees who a...
Location
Location
United States , Overland Park
Salary
Salary:
Not provided
https://www.t-mobile.com Logo
T-Mobile
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor's Degree OR combination of education and experience deemed equivalent
  • Acceptable areas of study include Human Resources or related field
  • 3+ years experience in Human Resources
  • 1-2 years prior experience in Customer Service role
  • 1- 2 years of experience in administering, assessing and coordinating mandated leaves, return to work and disability accommodation related to employment
  • Communication both verbal and in writing in an articulate, thorough responsive manner
  • Attention to detail and passion for high-quality work product
  • Customer Service skills to handle the sensitive and delicate personal situations that involve leave and disability
  • At least 18 years of age
  • Legally authorized to work in the United States
Job Responsibility
Job Responsibility
  • Reviews and enters exception time into our timekeeping system based on established leave related policies
  • Researches leave of absence dates with vendor to ensure accurate payment while the employee is on a leave of absence
  • Compiles leave of absence claim history for Legal related inquiries
  • Reviews, completes and submits state disability forms for employees to the state specific disability program
  • Manages ServiceNow tickets to trouble shoot employees’ questions related to leave and exception time, return to work issues, data corrections and other leave and pay related questions
  • Communicates with our vendor, employees, managers and HR regarding leave of absence related decisions
  • Periodically audits claim leave start and end dates across multiple systems to ensure data accuracy
  • Manages difficult situations with a professional and ethical demeanor (for example escalations, fraud, and guidance on employee action, EEOC or legal investigations)
  • Evaluates and applies federal and state legislation to T-Mobile practices and expertise to build trusted relationship with HR or field partners
  • Ensures accurate LOA status in HR, Timekeeping and Payroll databases
What we offer
What we offer
  • Competitive base salary and compensation package
  • Annual stock grant
  • Employee stock purchase plan
  • 401(k)
  • Access to free, year-round money coaches
  • Medical, dental and vision insurance
  • Flexible spending account
  • Paid time off
  • Up to 12 paid holidays
  • Paid parental and family leave
  • Fulltime
Read More
Arrow Right