20 Jul
Massachusetts,
Waltham
, 02451
Waltham
USA
Vacancy expired!
Job#: 1242871 Job Description: Senior Manager, GMP Quality Assurance Operations 1242871Job 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.
About Stratacuity:Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.PROVEN SCIENTIFIC PLACEMENT™Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us.Code: TechOpsEEO EmployerApex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or .
Vacancy expired!
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