The Clinical Trials Division (CTD) of Thermo Fisher Scientific is focused on providing end to end clinical trial solutions for our customers. We don’t specialize in any particular therapy – we support them all. Our customers range from small biotech/pharmaceutical startups to large pharmaceutical companies who focus on R&D and prefer to outsource supporting services for the execution of clinical trials across the globe. We have the industry’s largest global footprint of FDA cGMP facilities and regional hubs strategically located around the globe so we can be where our customers need us - we provide the full suite of services in each of those hubs so that we can get the right medication to the right patient on time.
The QA Contracts Director will lead a team of Quality contracts professionals working directly with Quality representatives for each CTD entity/site and the business, and is responsible for reviewing, drafting, negotiating and administering customer Quality (Technical) Agreements (QTAs) on behalf of the business. The QA Contracts Director will drive negotiation and closure of customer QTAs that meet CTD Quality policies, effectively mitigate risk to the business, satisfy GMP & applicable local regulatory requirements, and contribute toward achieving profitable growth. The QA Contracts Director will co-develop negotiation strategies with Quality representatives and the Legal Contracts team obtaining leadership approvals and coordinating with multiple resources (e.g., Client Services, Operations, Contracts and Legal) as needed. The QA Contracts Director will conduct internal and external GMP compliance audits to ensure compliance with applicable regulatory requirements, local regulations and applicable laws.
Essential Duties and Responsibilities:
- Lead a team of 2-4 Quality professionals who will draft, negotiate and administer Quality (Technical) Agreements in accordance with applicable organizational and departmental policies and procedures.
- Review, draft, negotiate and administer Quality (Technical) Agreements in accordance with applicable organizational and departmental policies and procedures.
- Ensure completion of applicable reviews and approvals of Quality (Technical) Agreements by required Quality personnel.
- Ensure that Quality Agreements from within the specific network (e.g., FCS) meet the same established quality standards and requirements.
- Coordinate systems and procedures related to processing of Quality (Technical) Agreements, including review processes for quality provisions. Collaborate with the Contracts to assist if necessary with the assembly of the final contract package for each customer/supplier and/or project.
- Perform Quality related risk assessment of proposed QA/GMP related Quality (Technical) Agreement provisions and develop recommendations to minimize their potential risk to the business.
- Track and report on Quality (Technical) Agreement statuses as required. Collaborate with Contracts to ensure accuracy on statuses.
- Assist in designing and implementing policies and procedures to effect the timely execution of Quality (Technical) Agreements.
- Assist in defining, establishing and implementing quality assurance/control procedures for Quality (Technical) Agreements, storage and compliance monitoring.
- Independently lead/participate internal/external GMP/Quality compliance audits as well as regulatory inspections. On occasion may work in a clean room environment that requires donning or gowning.
- Provide GMP compliance expertise to internal and external customers.
- Apply Good Manufacturing Principles in all areas of responsibility.
- Demonstrate and promote the company vision.
- Conduct all activities in a safe and efficient manner.
- Other duties may be assigned to meet business needs.
- Bachelor’s degree (Master degree or above desirable, preferably in a scientific discipline).
- At least 10 years of experience working in pharmaceutical or biotech industries; regulated GMP/Quality Systems Requirements (QSR) environment required
- At least 10 years Quality Assurance and/or Regulatory Compliance experience required. Expert on US FDA 21 CFR and EU regulations and guidelines for pharmaceutical drug product manufacturing, packaging, labeling, storage and distribution. Knowledge of IPEC, ISO, WHO, medical device regulations is desirable.
- Experience working in Clinical Trial Material (CTM)/ Investigational Medicinal Product (IMP) manufacturing and/or strong knowledge of CTM/IMP manufacturing and regulatory requirements preferred.
- Experience in Quality/GMP Auditing (internal, external and third-party and regulatory inspections) is desirable. QA records review/release experience for finished commercial and CTM/IMP is desirable.
- Substantive experience working with Contract Management Organizations (CMO), Clinical Research Organization (CRO), and suppliers/contractors in terms of reviewing, revising and negotiating Quality (Technical) Agreements.
- Experience developing and/or implementing Quality Agreement management program (systems and procedures).
- Excellent technical writing skills required; business / legal writing skills a plus.
- Ability to learn and adapt to computerized systems and databases used for Quality Agreement life-cycle management.
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