Pharma Quality Specialist Consultant Job at PA Consulting (Melbourn)

Non-Pharma Global Regulatory Affairs Specialist

The Global Regulatory Non-Pharma Specialist manages regulatory documentation and...

Location

Italy , Bologna

Salary:

Not provided

Alfasigma

Expiration Date

Until further notice

Requirements

At least 5 years’ experience in Regulatory Affairs preferably within the food supplements, medical devices, and cosmetics sectors
Exposure to regulatory operations or documentation in EU and/or RoW markets or similar experiences is preferred
Advance degree in Life Sciences, Pharmacy, Chemistry, or a related field
Relevant certifications in Regulatory Affairs are considered a plus
Good knowledge of EU regulations for medical devices (MDR, MDD) and relevant legislation for food supplements and cosmetics
Strong attention to detail, time management and organizational skills
Willingness to learn and ability to work effectively in a team-based environment
Strong communication and interpersonal skills
Proficiency in Microsoft Office Suite and familiarity with document management systems
Fluent in English, both written and spoken

Job Responsibility

Contributing in a cross-functional team to provide the necessary regulatory input for the development of new projects
Support regulatory strategies by providing impact assessments
Collaborate actively with the Research & Development team to integrate regulatory requirements during the design and development of assigned products
Prepare, organize and submit regulatory documentation for submission and maintenance of dossiers for the projects assigned
Coordinate with local affiliates and global stakeholders to ensure submissions are aligned with timelines and business priorities
Manage multiple tasks in a fast-paced environment while keeping on task and to the company’s quality standards
Contribute to the preparation of regulatory project updates in internal meeting and governance committee providing regulatory input and flagging risks
Assist colleagues with administrative tasks
Execute defined regulatory tasks within scope and deadlines under the guidance of the Head
Review and validate commercial artwork, packaging, and labeling in compliance with EU Regulations, ensuring timely product launches

What we offer

Competitive salary
Comprehensive benefits
Extensive opportunities for professional growth and development

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

QA Specialist

You will be a member of Pfizer’s dedicated and highly effective quality assuranc...

Location

Ireland , Dublin; Newbridge; Shanbally; Ringaskiddy; Little Island

Salary:

Not provided

Pfizer

Expiration Date

Until further notice

Requirements

Relevant Third Level Qualification or Equivalent (Exceptions may be considered where relevant skills/experience and correct attitude and behaviours exist (this may be supplemented by further education in parallel)
Minimum 2 years experience as detailed above in the job responsibilities section, within a QA/QC GMP environment in a Pharma/Biotech company
Excellent communication and interpersonal skills
An ability to work independently, as well as a member of a team in a dynamic, fast-paced environment
Proactive approach and strong critical thinking skills

Job Responsibility

Support operations through real time batch review ensuring all batch manufacturing records (paper / electronic) and associated manufacturing deviations are reviewed in a timely manner and in accordance with release schedules
Support issue resolution, incident routing and deviations
Complete walkthrough audits to ensure the area is maintaining cGMP compliance standards
Attend IMEx meetings and ensure timely escalation of issues to the QA Manager
Accurately communicate Supply/Operational needs/perspectives as well as Quality Operations (QO) perspectives
Review and approval of validation documents Process, cleaning & method validation
Review and approve master batch records and executed batch records to assure compliance with regulatory standards and regulatory filings
Ensure that production instructional documentation (SOPs and batch records) are up to date, compliant, and supports RFT (right first time) production, and that all in -process control limits and specifications have been met
Review all operational SOP’s, forms, protocols and reports, and any related documentation as applicable
Ensure all batch deviations are reported in accordance with Pfizer corporate standards

Fulltime

Sr Director, MSAT

The Sr. Director, MSAT (Manufacturing Sciences, Analytics, and Technology) acts ...

Location

United States , Bedford

Salary:

Not provided

PCI Pharma Services

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Life Sciences or equivalent experience required
Minimum of fifteen (15) years of relevant experience in cGMP manufacturing or equivalent
Proven experience leading innovation, managerial experience with extensive industry knowledge and an eye towards future technologies
Soft skills: Strategic thinking, adaptive thinking, and strong critical mindset. Strong business acumen and presentation skills. Excellent interpersonal, leadership, and communication skills. Impact & influence top leaders & external clients and regulators
Emphasis on aseptic processing and compliance required
Advanced-level verbal communication skills

Job Responsibility

Optimize the use of resources (human, fill finish equipment and support areas) across the organization in support of improving process robustness and forward-looking capabilities
Coordinates and supports cross functional teams with recommendations, advice, and action plans for complex investigations, change controls, gap analyses and risk assessments related to all manufacturing modalities
Oversees authoring and revision of compliance, change controls and other technical documentation to support critical MSAT changes
Assesses incoming client projects to ensure compatibility, compliance, and initial and ongoing profitability with AAI processes
Contributes advanced level support to internal and client audits when needed
Build and sustain common innovation roadmap between MSAT and Drug Product Manufacturing/Finishing to ensure continuum in innovation to accelerate client projects and sustainable process performance
Lead the client technical intake process team composed of engineers and specialists
Drive complex change management & anchor the changes in MSAT and with connected functions, Drug Product, Finishing, Quality Assurance and Quality Control
Responsible for exhibiting professional behavior with both internal and external business associates that reflect positively on the company and is consistent with the company’s policies and practices
Serves as key contact for clients during tech transfer and post manufacturing activities

Fulltime

New

Senior Lecturer/Associate Professor in Literacy

As a Senior Lecturer / Associate Professor in Literacy, you will play a key role...

Location

Australia , Albury-Wodonga, Bathurst, Port Macquarie, Wagga Wagga

Salary:

Not provided

Charles Sturt University

Expiration Date

June 08, 2026

Requirements

A doctoral qualification relevant to literacy or education, with a recognised teaching qualification
A strong record of high-quality teaching and student-centred learning
An established or emerging research profile aligned to literacy, curriculum or pedagogy
The ability to build productive partnerships and contribute to academic leadership

Job Responsibility

Lead impactful literacy teaching and research
Teach across online and on-campus environments
Shape future teachers and education practice
Contribute to curriculum innovation
Build strong relationships with students and partners
Provide academic leadership in literacy education
Contribute to the School's research profile
Supervise higher degree research students
Actively engage with professional, community and government stakeholders
At Associate Professor level: significant academic leadership, research impact, and contribution to the broader discipline at national/international level

What we offer

17% superannuation

Fulltime

New

Program Manager - Controls and Avionics Solutions

This position is based in Endicott, New York. New York and on-site work will be ...

Location

United States , Endicott

Salary:

120874.00 - 205486.00 USD / Year

Baesystems

Expiration Date

Until further notice

Requirements

Bachelor’s degree in engineering, engineering or manufacturing management, or other discipline
Demonstrated ability for building strong customer/ stakeholder relationships
Strong communication, negotiation, and presentation skills
Ability to interpret data and make data-driven decisions
Highly adaptable with strong initiative
Demonstrated ability to lead and motivate cross-functional teams
Knowledge of the global aviation market and regulatory requirements and/ or military aviation market

Job Responsibility

Maintaining strong customer relationships and leading a multidisciplinary team to execute complex development programs within schedule and budget
Leadership and management oversight of a project team assuring that project’s financials, schedule, and technical objectives are met and that the highest level of customer satisfaction is achieved while meeting all contractual commitments
Work effectively and collaboratively with Engineering, Operations, and all Program Office functional leadership to assure deliveries continue to exceed customer commitments and achievement of financial commitments to the company
Manages, coordinates, plans, organizes, controls, integrates, and executes projects within the Military Aircraft Systems portfolio
Participates in the support of new business and in the development of proposals

What we offer

Health insurance
Dental insurance
Vision insurance
Health savings accounts
401(k) savings plan
Disability coverage
Life and accident insurance
Employee assistance program
Legal plan
Discounts on home, auto, and pet insurance

Fulltime

New

Finance Business Partner (Research)

Full Time, Fixed Term (12 months). Level 7 - $101,421 to $110,819 p.a. (plus 17%...

Location

Australia , Wagga Wagga

Salary:

101421.00 - 110819.00 AUD / Year

Charles Sturt University

Expiration Date

June 02, 2026

Requirements

A degree in Accounting or Finance (professional accounting body membership is desirable)
Experience in project budgeting, forecasting and financial analysis
Background in management accounting or business partnering within complex environments
exposure to government funding or higher education is advantageous
Excellent stakeholder engagement skills, with the ability to work effectively with academics and researchers
Familiarity with business intelligence systems and dashboard reporting

Job Responsibility

Partner with academics to deliver strategic financial insights that enable research success
Directly influence world-class projects and decisions shaping the future of education and innovation
Lead initiatives that enhance financial governance, deliver accurate and timely reporting, and support key projects such as cost-pricing systems and research budgeting
Help build financial capability across the University, fostering collaboration and continuous improvement

What we offer

Flexibility with a 35-hour work week
Access to hybrid work arrangements
17% superannuation

Fulltime

New

Associate Lecturer/ Lecturer in Oral Health

Make a real impact by educating future oral health professionals to serve the ur...

Location

Australia , Wagga Wagga

Salary:

80046.00 - 134965.00 AUD / Year

Charles Sturt University

Expiration Date

June 16, 2026

Requirements

A qualification relevant to the discipline and appropriate to the level being applied for
Full registration (for teaching/research) as a Dentist or Oral Health Therapist with the Australian Health Practitioner Regulation Agency (Ahpra)
Excellent understanding of the clinical practice of oral health therapy, supported by a record of teaching and subject coordination relevant to the discipline and appropriate to the level being applied for
Evidence of the delivery of high quality student-centred learning and teaching in oral health therapy and/or general dentistry
A record of research activity or capability relevant to the discipline and appropriate to the level being applied for, as outlined in the position descriptions, may facilitate the progression of research opportunities

Job Responsibility

deliver high-quality teaching, clinical supervision and learning experiences in Oral Health
work with students in both clinical and preclinical settings while contributing to curriculum development, industry engagement and community partnerships

What we offer

Generous support provided to assist with relocating to Riverina’s beautiful Wagga Wagga or surrounds
17% superannuation

Fulltime

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Pharma Quality Specialist Consultant

PA Consulting

Location:
United Kingdom , Melbourn

Category:
Consulting

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
April 24, 2026

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