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QA, Quality System and Compliance, Sr. Manager/Associate Director

Status: Active
CompanyRVAC Medicines
LocationBoston, MA
Expiration2023-06-14
How to Apply

Please send you resume to CareerDevelopment@rvacmed.com

Responsibilities:

1. Provides leadership, guidance, and oversight of the Quality Systems. Work with functional teams to establish and implement Corporate Quality standards, ensure site procedures, processes and systems meet current GxP and regulatory expectations.

2. Establishes strategy and plans for qualification and oversight of strategic partners, including CROs for non-clinical and clinical studies, CMOs for IMP and commercial product manufacturing, contracted testing labs, and auditing service provider. 

3. Serves as point of contact for Quality with external partners. Review significant deviations and perform regulatory assessment for change controls as well as manage/attend periodic business reviews with the CRO/CMO.  Accountable for the product/service quality performance at designated CRO/CMO, to ensure compliance and quality risks are identified, communicated, and mitigated, and are an integral part of business decisions consistent with cGxP and company Quality Standards.

4. Establish Regulatory Intelligence review, internal audit, and quality risk management program to proactively identify opportunities for continuous improvement of quality performance.

5. Ensure sites’ inspection readiness.

6. Execute on Quality Improvement projects where appropriate. For example, the implementation of eQMS system, R&D Data Integrity best practice, etc.

Qualification:

1. Bachelor’s degree or above in life sciences or related fields, 10y+ experience in bio-pharmaceutical industry.

2. 8y+ in a cGMP regulated environment, including site QA /QC, and corporate quality management experience. Experience with Quality System management, deviation investigation, and change control are required.

3. External supplier management experience highly preferred.

4. Thorough knowledge of and working experience on international cGxP and pharmaceutical regulatory requirements (FDA 21CFR part 11, 58, 210&211, 600, 610; EU-GMP and EU Annex; ICH guidance).

5. Good communication skills, team player, ability to influence outside the area of responsibility.

6. Willing to work during non-routine hours (ad hoc evening meetings) to collaborate with global team members.

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