GMP Operational Quality Sr. Manager (Contract)

The Sr. Manager will provide critical support in ensuring that Quality Systems and documentation are fully launch ready for commercial biologics and combination products. This individual will collaborate cross-functionally with internal stakeholders and external suppliers to ensure compliance, readiness, and alignment with regulatory expectations and company standards. The role requires deep expertise in biologics and combination product quality systems, document management in Veeva Vault, and supplier oversight.

Key Duties and Responsibilities:

• Lead and execute Quality System readiness activities to support commercial launch of biologic and combination product programs.
• Assess and revise existing quality system documentation to ensure compliance with global regulations (21 CFR, EU Annex 1, ISO 13485, etc.) and commercial product expectations.
• Perform and manage document revisions, routing, and approvals within Veeva Vault QMS, ensuring controlled, audit-ready documentation.
• Partner cross-functionally with Manufacturing, Supply Chain, Regulatory, Device Development, and Quality Operations to align on commercial launch deliverables.
• Support gap assessments and implementation plans to ensure quality systems are modality-agnostic/inclusive and fit for biologics and combination products.
• Collaborate with external CMOs, suppliers, and device partners to ensure quality agreements, change controls, and readiness activities are executed per plan.
• Provide QA oversight for supplier quality activities and coordinate with internal Vendor Quality Management teams to ensure supplier compliance and inspection readiness.

Knowledge and Skills:

• Bachelor’s degree in Life Sciences, Engineering, or related field (advanced degree preferred).
• 8+ years of experience in Quality Assurance within the biopharmaceutical or medical device industry, including experience in commercial biologics and combination products.
• Proven track record of ensuring quality system readiness for product launch.
• Hands-on experience with Veeva Vault (document revisions, change control, and approval workflows).
• Strong understanding of global GxP regulations, quality systems, and industry best practices.
• Experience collaborating with external suppliers and managing quality deliverables across multiple partners.
• Excellent communication, organizational, and problem-solving skills with the ability to work independently in a fast-paced environment.

Preferred Experience:

• Commercial launch readiness for biologic and combination products.
• Experience in cross-functional collaboration with technical, supply chain, and device teams.

Contract Length: 6 month with a chance to extend

75$/hr.-85$/hr.

Monday - Friday

This job posting is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals (“Vertex”). The individual selected for this role will be offered the role as an employee of a third- party agency partner; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors, including skills, competencies, experience, location and/or being pursued and other job-related factors permitted by law. In addition, this role will be eligible for overtime pay, in accordance with federal and state requirements

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