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Location

South San Francisco, CA | United States

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Job description

Location: 100% Remote
Duration: 06 months-Contract
Client-Pharma
W2 Acceptable-100% Remote Role

Job Description:
Position Summary:
The Quality Contracts Manager, will work directly with Quality Representatives for each Pharma Services Group (PSG) entity/site, and is responsible for reviewing, drafting, negotiating and coordinating client Quality (Technical) Agreements on behalf of the business. The Quality Contracts Manager will work with to negotiate and close Quality (Technical) Agreements that meet PSG 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, Strategy and Operations, acquiring leadership approvals and coordinating with multiple resources (e.g., Client Services, Operations, Contracts and Legal).
No more than 2-3 sentences
A day in the Life:
Review, draft, negotiate and coordinate Quality (Technical) Agreements in accordance with applicable PSG 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, PSG) 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 PSG 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.
Education
Minimal requirements include a Bachelor degree in a scientific field (preferably Chemistry or Biology).
Experience
At least 6 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 solid understanding of CTM/IMP manufacturing and regulatory requirements. Pertinent GMP experience in packaging, labeling, and distribution environments will be advantageous.
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 helpful.
Possess excellent interpersonal, organizational/project management, analytical and negotiation skills including interacting 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.
Proficiency with the latest MS Office products, including Outlook, Word, Excel, and related electronic tools for editing, documenting, tracking and communication.
Knowledge, Skills, Abilities
Effective negotiation skills
Effective time management and prioritization skills.
Excellent business acumen with a strong working knowledge of clinical and commercial GMPs
Proven ability to build partnerships and work across matrixed organization
Employment Type: Contractor

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Job tags

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Salary