Combination Product Quality Specialist Consultant Job at PA Consulting (London)

Combination Product Quality Specialist Consultant

We believe in the power of ingenuity to build a positive human future. As strate...

Location

United Kingdom , Melbourn

Salary:

Not provided

PA Consulting

Expiration Date

Until further notice

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

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

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

Storage Sales Specialist

As a Storage Sales Specialist, you will position HPE Storage solutions, expand c...

Location

Germany , Southern Germany

Salary:

Not provided

Hewlett Packard Enterprise

Expiration Date

Until further notice

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

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

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

Storage Sales Specialist

Sales Specialist for HPE Storage solutions located in Berlin, Germany. Responsib...

Location

Germany , Berlin

Salary:

Not provided

Hewlett Packard Enterprise

Expiration Date

Until further notice

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

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

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

Senior Product Specialist, VISIA® CRP

We are seeking a Senior Product Specialist – VISIA‑CRP to play a critical role i...

Location

Salary:

75000.00 - 95000.00 USD / Year

canfield scientific

Expiration Date

Until further notice

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

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

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

New

Pharma Quality Specialist Consultant

Hybrid working - our approach is to be in the office or on client site a minimum...

Location

United Kingdom , London

Salary:

Not provided

PA Consulting

Expiration Date

Until further notice

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

QMS design and process transformation
Leading the design and implementation of GxP-compliant QMS across R&D, manufacturing, clinical and distribution environments
Conducting process mapping and gap assessments, and supporting the rollout of new or enhanced systems aligned to global regulatory standards (including GMP, GDP, GCP, GLP, FDA 21 CFR 210/211, EU GMP/EudraLex, ICH Q7/Q10)
Authoring, reviewing and maintaining quality policies, standards, SOPs, forms and controlled documentation, enabling sustainable compliance and operational excellence
Supporting effective change management, embedding best practices through close collaboration with quality, technical and business teams
Computer system validation and data integrity
Leading and advising on computer system validation (CSV) activities within GxP environments
Supporting the development of validation strategies, protocols, test scripts and data integrity controls in line with global regulatory expectations
Supplier quality and audit support
Applying hands-on experience in supplier qualification, evaluation and audit activities (internal and external)

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

Pharma Quality Specialist Consultant

Our Life Sciences teams work with leading pharmaceutical, biotechnology and heal...

Location

United Kingdom , London

Salary:

Not provided

PA Consulting

Expiration Date

Until further notice

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

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

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

Senior Manager Dairy Sanitation

We are looking for an experienced Senior Manager to lead our Dairy Sanitation pr...

Location

United States

Salary:

100700.00 - 155100.00 USD / Year

Cencora

Expiration Date

Until further notice

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

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

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

QA Specialist II - Operations

The QA Operations Specialist II – Floor Support is responsible for providing QA ...

Location

United States , Bedford

Salary:

Not provided

PCI Pharma Services

Expiration Date

Until further notice

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

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

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Combination Product Quality Specialist Consultant

Job Description

Job Responsibility

Requirements

Nice to have

What we offer

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