Freelance/Contract QA CMC Consultant (Director level)

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For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

ProPharma is currently supporting a development client within the Biological space as they require a Senior Consultant to support them in the QA/CMC area. At present the project will commence at the start of 2026; it will run until the end of 2028 and requires approx. 5-8 hours per week support. The project is to lead and create a Quality system for CMC Quality management and will be key in managing CMO partners and providing QA oversight.

Responsibilities

• Develop quality system for CMC Quality Management
• Quality management of contract manufacturing organizations (CMOs)
• QA oversight of CMOs which includes periodic audits of CMOs and testing laboratories
• Establish and manage quality agreements
• Oversee quality processes relevant to outsourced activities: Change control; Deviation/CAPA management; Product release; Annual product reviews. Conduct quality risk assessments of CMOs
• Review and approve all quality records generated by CMOs
• Leadership as QA Head
• Train internal staff on CMO quality oversight practices

Experience Required

• Must be educated to a BSc or higher within a Life-Sciences discipline or a related field with suitable industry experience
• Proven experience working at a senior level within Quality Assurance is a must
• Demonstrated experience building a Quality Management system would be preferred or at least management at a senior level
• CMC experience would be preferred ideally within a QA CMC role
• QA CMO management experience is a must
• Strong skills linked to aseptic/sterile products
• Fluency in English
• Can perform the project as described within the job spec
• Overall guidance and support from a QA CMC perspective as a SME

We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.

All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us – whether you\\\’re successful or not.

ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.

Seniority level

• Director

Employment type

• Part-time

Job function

• Quality Assurance
• Industries: Business Consulting and Services

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