QA Specilaist
Senior Quality Assurance Consultant (GMP Manufacturing Operations)
We are currently supporting a major pharmaceutical manufacturing organisation on a high-profile quality and compliance improvement programme and are seeking experienced Senior Quality Assurance professionals to join on a contract basis.
This opportunity is specifically aimed at individuals who have held leadership positions within GMP-regulated manufacturing environments and can provide hands-on support across quality operations, manufacturing oversight, and compliance activities. We are particularly interested in speaking with professionals who have previously operated as QA Managers, Senior QA Managers, Heads of Quality, Directors of Quality, Quality Operations Leads, or similar senior-level quality leadership positions within the pharmaceutical, biotechnology, or sterile manufacturing sectors.
Key Responsibilities
- Provide QA leadership and oversight across GMP manufacturing operations.
- Support and mentor operational quality teams on the manufacturing floor.
- Act as a key Quality representative within production and operational meetings.
- Ensure compliance with GMP regulations, internal quality systems, and site procedures.
- Review, approve, and provide guidance on quality documentation, investigations, and manufacturing records.
- Lead or support deviation investigations, CAPAs, change controls, risk assessments, and quality improvement initiatives.
- Drive inspection readiness activities and support regulatory authority inspections.
- Assist with remediation programmes, quality transformation initiatives, and compliance improvement projects.
- Partner closely with Manufacturing, Engineering, Validation, and Quality Control teams to ensure effective quality oversight.
- Provide strategic guidance on quality operations within aseptic, sterile, or biopharmaceutical manufacturing environments.
Desired Experience
Successful candidates will have demonstrated experience in several of the following areas:
- QA Shop Floor Oversight
- Quality Operations Leadership
- GMP Manufacturing Oversight
- Manufacturing Compliance and Quality Systems
- Aseptic Processing and Manufacturing Support
- Sterile Fill-Finish Operations
- Biopharmaceutical Manufacturing Environments
- Deviation Management and Root Cause Investigations
- CAPA Development and Effectiveness Monitoring
- Change Control and Risk Management
- Regulatory Inspection Preparation and Support
- FDA, EMA, MHRA, or other global regulatory interactions
- Compliance Remediation and Quality Improvement Programmes
Candidate Profile
- Extensive experience within pharmaceutical, biotechnology, biologics, vaccine, or sterile manufacturing facilities.
- Proven track record operating in senior quality leadership positions.
- Strong stakeholder management skills, with the ability to influence teams across multiple functions.
- Comfortable providing both strategic direction and practical, hands-on support.
- Previous consulting or contractor experience would be highly advantageous, although not essential.
- Experience supporting sites through periods of rapid growth, regulatory scrutiny, inspection preparation, or quality transformation is highly desirable.