Job#: 1242871 Job Description:
Senior Manager, GMP Quality Assurance Operations 1242871
Job Scope & Purpose:
Our client is a clinical stage biologic therapeutic company developing antibody and small molecule therapeutics for challenging diseases. We are seeking a qualified GMP QA Operations leader to oversee batch record review, and approval of manufacturing operations while supporting the implementation of scalable QA processes. The primary objective is to ensure manufacturing processes are capable, compliant, in control, and continuously improved. This is a highly visibility position that will be part of an executive team internally and with partner organizations. This job has the flexibility to be hybrid and they are based out of Waltham, MA.
Primary Job Responsibilities
- Own the responsibility for clinical batch disposition. Ensure review of batch data, including batch records, deviations, and other quality systems as applicable to determine acceptability of product disposition.
- Serve as the Quality lead to support product risk assessments, supporting the identification of Quality risks and appropriate mitigation plans to achieve compliant solutions.
- Review and approve quality events such as deviations, CAPA, and Change Control, performing Failure Mode and Effect Analyses, root cause analyses, and CAPA effectiveness check, as required.
- Develop, monitor, and improve quality processes, ensuring scalability and sustainability to meet the growing needs of the organization.
- Assist in developing Quality Plans and metrics to monitor QMS effectiveness and communicating results to senior management via management review.
- Oversee quality audits when needed
Primary Job Requirements
- 10+ years of experience in related Biopharmaceutical Quality Operations or Compliance roles, with at least 6 years of experience in Quality Operations.
- BA or BS is preferred though long-time experience in QA may be acceptable.
- Strong interpersonal and organizational skills, and attention to detail.
- The ability to provide subject matter expertise regarding GMP operations and CMO management.
- Strong leadership skills with the ability to thrive in a high throughput environment.
- Ability to lead and manage projects and teams within corporate objectives and project timelines.
- Previous experience with CMO management including previous audit exposure
- Entrepreneurial and results driven mindset, and the ability to work with little instruction.
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