Executive Director, Quality Assurance Head

2 weeks ago

Rockville, United States AbelZeta Inc Full time
Job DescriptionJob Description

AbelZeta is a clinical stage biopharmaceutical company focused on the development of novel immunotherapy products. AbelZeta operates a state-of-the-art facility in Rockville, Maryland with five GMP rooms in order to augment its global research and development capabilities and to support clinical development of multiple cell therapy platform technologies in the US. We are on a rapid growth trajectory and have a highly energized and accomplished team driving to new frontiers of care for cancer and autoimmune disease patients. We are seeking a Quality Assurance Head to join our team.

The Quality Assurance Head will lead and oversee all aspects of quality assurance activities to ensure compliance with current GMP requirements. This role involves strategic oversight, leadership, and management of QA processes to maintain the highest standards of compliance in all operations.

Responsibilities and Duties:

  • Strategically direct the site to develop and maintain phase-appropriate GMP Quality System to support and drive compliance. Oversee the development and improvement of quality processes that both scalable and sustainable.
  • Manage Quality Compliance/Quality System, QA Operations, and Quality Engineering functions and provide oversight to all QA activities, including document control, review and approval of master production records, failure investigation, impact assessments, CAPA management, and quality audits.
  • Lead the Quality Assurance team in the review and approval of executed production records and other relevant GMP documentation to ensure timely disposition of clinical products.
  • Provide high-level QA support for resolving issues related to materials, in-process products, final products, environmental factors, and equipment manufacturing.
  • Participate in the strategic planning and execution of quality-related activities.
  • Collaborate cross-functionally with manufacturing, CMC development, regulatory affairs, and clinical operations, to ensure quality considerations are integrated into all aspects of product supply.
  • Serve as the primary QA representative in executive leadership meetings, providing expert guidance on quality-related matters.
  • Provide strategies to address compliance gaps or determine enhancements to cross-functional quality systems.
  • Ensure that all manufacturing process, testing activities, and validation activities are performed and documented following approved procedures and protocols.
  • Hosts and acts as subject matter expert for GMP operations during audits; ensures any audit observations are adequately addressed and completed on time.
  • Perform other duties and tasks as assigned.

Qualifications and Requirements:

  • B.S. degree in a scientific discipline (e.g., Biology, Chemistry, Biochemistry) or related field; Master or PhD preferred.
  • Minimum of 10 years of progressive experience in Quality Assurance within the biopharmaceutical industry, experience in cell therapy highly preferred.
  • Proven track record of successful leadership in a senior QA role
  • Understanding of cell therapy and drug product development and manufacturing.
  • In-depth knowledge of cGMP and trends pertaining to the manufacture and testing of biopharmaceuticals is preferred.
  • Previous experience working in a cross-functional team in a matrix environment is a plus.
  • Excellent written and verbal communication skills, including facilitation and presentation skills are important.

Why You Should Join AbelZeta

  • Join a high-growth and fast-paced organization.
  • Defined career path and annual performance review and feedback process.
  • Comprehensive Benefits Plan, including 100% company paid medical, dental, vision, life Insurance, short-term and long-term disability insurance, and more
  • Competitive company 401k match.
  • Paid holidays, sick leave, and annual leave.

AbelZeta is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. AbelZeta validates right to work using E-Verify. Salary at AbelZeta is determined by various factors, including but not limited to location, the individual’s particular combination of education, knowledge, skills, competencies, and experience, as well as contract-specific affordability and organizational requirements. The estimate displayed represents the typical salary range for this position and is just one component of AbelZeta’s total compensation package for employees.

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