Location
Waltham, MA | United States
Job description
Job Description
Our client’s Quality team is growing and we are currently seeking a Manager/Senior Manager of GMP QA Operations to play a pivotal role in ensuring the quality and compliance of our manufacturing processes as we progress toward commercialization. Reporting to the Sr. Director, QA Operations, the Manager will oversee a team responsible for overseeing manufacturing, batch record release, investigations, deviations, CAPAs, and change controls within our GMP operations.
Key Responsibilities Include:
Manufacturing Oversight: - Lead and oversee GMP manufacturing activities, ensuring compliance with regulatory requirements and internal quality standards
- Collaborate with cross-functional teams to streamline manufacturing processes and maintain product quality
- Provide leadership and guidance to the manufacturing team to ensure compliance with GMP (Good Manufacturing Practices) regulations
- Provide GMP guidance to third-party vendors to ensure product meets quality expectations and compliance of products with cGMP
- With limited guidance, support and/or lead continual improvement initiatives in order to realize operating efficiencies in support of product release
- With limited guidance, help and support the QP audit process for approval of assigned product and batches outside USA
Batch Record Release:
- Manage the batch record review and release process to ensure timely and compliant release of clinical batches
- Review batch records for accuracy and completeness and address any discrepancies or deviations
Investigations, Deviations & Change Control:
- Lead investigations into manufacturing discrepancies, deviations, and non-conformities, ensuring thorough root cause analysis and effective corrective and preventive actions (CAPAs)
- Develop and implement corrective and preventive actions (CAPAs) to prevent recurrence of issues
- Assess the impact of changes on product quality and regulatory requirements
Quality Assurance Leadership:
- Provide guidance, mentorship, and leadership to the QA Operations team
- Foster a culture of continuous improvement and commitment to quality
- Collaborate cross-functionally with R&D, Manufacturing, Regulatory Affairs, and other departments to facilitate effective communication and resolution of quality-related issues
Continuous Improvement:
- Identify opportunities for process improvements and efficiencies within the QA Operations function, driving continuous improvement initiatives
Qualifications:
- Bachelor's degree in a relevant scientific or engineering discipline; advanced degree preferred
- Minimum of 8 years of experience in Quality Assurance within the pharmaceutical or biotechnology industry
- Strong understanding of GMP regulations and quality standards. Experience with Combination products a plus
- Previous experience in a leadership or managerial role
- Excellent communication, problem-solving, and decision-making skills
- Ability to work effectively in a fast-paced, dynamic environment
- Detail-oriented with a commitment to quality and compliance
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