Contract Manager, Quality
US - Arizona - Remote / Field, US - California - Remote / Field, US - Florida - Remote / Field, US - Georgia - Remote / Field, US - Indiana - Remote / Field, US - Louisiana - Remote / Field, US - Maryland - Remote / Field, US - New Jersey - Remote / FieldUpdate time: August 4,2020
Job Description
When you’re part of Thermo Fisher Scientific, you’ll do challenging work, and be part of a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. With revenues of $20 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.
Position Summary:
The Quality Contracts Manager, will work directly with Quality Representatives for each Clinical Trials Division (CTD) entity/site, and is responsible for reviewing, drafting, negotiating and administering client Quality (Technical) Agreements on behalf of the business. The Quality Contracts Manager will work with Quality representatives to negotiate and close Quality (Technical) Agreements that meet CTD Quality policies and GMP requirements in order to support the business to achieve profitable growth. The Quality Contracts Manager will co-develop negotiation strategies with Quality representatives and the Quality Director, Contracts Management, obtaining leadership approvals and coordinating with multiple resources (e.g., Client Services, Operations, Contracts and Legal).
The Quality Contracts Manager, will ensure Quality (Technical) Agreement compliance with applicable regulatory requirements, local regulations and applicable laws.
Responsibilities:
- Review, draft, negotiate and administer Quality (Technical) Agreements in accordance with applicable CTD policies and procedures.
- Ensure completion of applicable reviews and approvals of Quality (Technical) Agreements by required Quality personnel.
- Include QP tasks are incorporated into the Quality (Technical) Agreements
- Ensure that Quality (Technical) 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.
- 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 other team members 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 processes for Quality (Technical) Agreements, storage and compliance monitoring.
- Provide GMP compliance expertise as pertaining to Quality (Technical) Agreement provisions to internal and external customers.
- Liaise with Client quality personnel and be able to mitigate CTD expectations and questions.
- Demonstrate and promote the company vision.
- Conduct all activities in a safe and efficient manner.
- Other duties may be assigned to meet business needs.
Minimum Requirements/Qualifications:
- At least 10 years’ experience working in pharmaceutical, biotech industries, regulated GMP/ environment required with a Bachelor degree (Master degree or above desirable, preferably in a scientific discipline).
- At least 5 years Quality Assurance and/or Regulatory Compliance experience required. Experience with EU GMP regulations and guidelines for pharmaceutical drug product manufacturing, packaging, labeling, storage and distribution. Experience with EU Qualified Person (QP) and/or Swiss Responsible Person (RP) regulations is a plus. Experience with US FDA GMP regulations is also needed. 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. Pertinent GMP experience in packaging, labeling, and distribution environments will be highly desirable.
- Experience developing and/or implementing Quality (Technical) 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 (Technical) Agreement life-cycle management.
- Ability and experience working with other (besides quality and operations) personnel such as contracts/legal, project management, business development, client services is highly desirable.
- Possess excellent organizational, project management, analytical and negotiation skills including dealing with different types of personalities internally and with our clients.
- Excellent attention to detail, and excellent communications skills both written and verbal, including presentation skills.
- Demonstrated proficiency with the latest MS Office products, including Outlook, Word, Excel, and related electronic tools for editing, documenting, tracking and communicating
Education/ Experience:
- Minimal requirements include a Bachelor degree in a scientific field (preferably Chemistry or Biology).
- At least 10 years Quality Assurance and/or Regulatory Compliance experience, including 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 with clinical trial manufacturing processes is highly preferred.
Ability and/or Skills :
- Excellent business acumen with above average oral and written communications skills to support contract negotiations at all levels.
- Customer orientation; demonstrated ability to build partnerships with internal and external customers.
- Considerable time line pressures require a sense of urgency and self-management.
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