Manager of Quality Assurance Operations

Manager of Quality Assurance Operations - Contract - Cambridge, MA

Proclinical is seeking a Manager of Quality Assurance Operations to join a dedicated team.

Primary Responsibilities:

This role will assist with all GMP aspects of drug product manufacturing and alliance management. The successful candidate will work closely with Quality Operations to ensure that clinical and commercial lifecycle activities comply with cGMP regulatory requirements. This position involves collaboration with internal and external partners to maintain high-quality standards.

Skills & Requirements:

• Degree in life sciences, engineering, or related field.
• Minimum of 5 years experience in Quality Assurance within pharmaceutical or biopharmaceutical companies.
• Familiarity with external Contract Manufacturing Organizations in a virtual setting.
• Knowledge of aseptic techniques and parenteral drug manufacturing operations.
• Experience with GMP management and exposure to regulatory authorities like FDA, EMA, PMDA, or ANVISA.
• Preferred experience with investigational and commercial products in Quality Operations.
• Experience working with Alliance Partners is a plus.
• Ability to improve processes and turnaround times.

The Manager of Quality Assurance Operations' responsibilities will be:

• Oversee quality assurance for external manufacturing of clinical and commercial drug products.
• Review and approve internal and external Deviations, Change Controls, and CAPAs.
• Support QA review and data verification for clinical regulatory filings.
• Collaborate with alliance partners to ensure compliance with quality systems and practices.
• Work with colleagues and vendors to address complex quality issues and find compliant solutions.
• Report timely and accurate metrics for KPI and risk register tools.
• Drive continuous improvement to mitigate risks and support business needs.

If you are having difficulty in applying or if you have any questions, please contact Anderson Maldonado at a.maldonado@proclinical.com

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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