AavantiBio is seeking an Executive/Senior Director, External Quality Assurance, responsible for quality assurance oversight of all external CMO, Contract Laboratories and critical Starting Material Manufacturer activities, including but not limited to providing quality leadership for Tech Transfers between sites and CMOs, supporting major/critical investigations and supporting inspections.
· Full-time salary position with the opportunity for annual bonuses and participation in the Equity Incentive Plan. Benefits include high-quality health insurance plans including both gold and platinum Blue Cross Blue Shield plans, for which AavantiBio pays a competitive 85% of the health insurance premiums for our employees and their families. In addition to health insurance, we have put in place flexible spending accounts and other benefits for our employees, including dental, vision, short- and long-term disability, group life insurance, AFLAC, and more. To assist our employees with their retirement planning, AavantiBio offers a safe-harbor 401(k) plan with a generous 6% company match.
Responsibilities – These may include but not limited to:
- Leads and manages resources and budget within External Quality and drives an ongoing organizational transformation towards the future AavantiBio gene therapy strategic horizon.
- Provides leadership, mentoring, and coaching for the subordinates in the External Quality team; supporting their career development in line with the business needs in the External Quality Department and/or the overall AavantiBio Gene Therapy Quality Organization.
- Partners with and leverages similar expertise in the AavantiBio Quality Organization and identifies opportunities for External Quality process optimizations and continuous improvements.
- Identifies critical compliance and/or business issues related to CMOs, Contract Laboratories, and Manufacturers of critical starting materials. Creates remediation strategies and tactical plans as needed using a risk management-based approach.
- Participates as a core member in the External Manufacturing team providing the Quality Assurance oversight.
- Partners with internal Stakeholders: External Supply Organization, Supply Chain, Manufacturing Science & Technology, Manufacturing Operations, Regulatory Affairs, Global Quality Functions in AavantiBio Gene Therapy.
- Collaborates with External Partners: CMOs, Contract Laboratories, and critical starting materials Manufacturers to ensure uninterrupted supply ensuring full support to current and future AavantiBio Gene Therapy Manufacturing.
- Supports the major/critical deviations and events investigations minimizing risk on product quality, efficacy, and safety.
- Create and lead a culture of quality throughout the company to help ensure compliance with all applicable regulations, corporate standards, policies, and procedures
- Manage the development and reporting of Quality metrics and periodic reporting describing compliance trends and any areas of risk with associated mitigation plans
- Ensure that the company, its contractors, and vendors are prepared for FDA and Health Authority inspections and host these inspections
- Leads escalations related to External Quality activities for critical issues.
- Supports the inspection readiness program in regards to CMOs, contract Laboratories, critical starting materials, and suppliers and coordinates responses needed for External Quality topics.
- Creates and maintains External Quality metrics.
- Other Job-related duties determined during the annual objectives setting process and by the key performance indicators.
Qualifications, Knowledge, Skills, and Abilities
- B.S. M.Sc, or Ph.D. degree, preferably in microbiology, chemistry, or biochemistry. M.Sc. is preferred.
- Minimum 10-12 years of experience in pharmaceutical or biologics with a minimum of 5-7 years' experience in Quality Operations and/or external Manufacturing management.
- Gene Therapy, Biologics, or vaccine experience is preferred.
- Minimum of 5 years of direct supervisory experience with budget management.
- Comprehensive knowledge of FDA and EMA regulations and experience in interaction with US and international regulatory agency inspections.
- Experience in hosting FDA and Health Authority inspections
- Experience working with US and EU CMOs and clinical sites
- Experience and success in a dynamic, complex, and fast-paced team environment
- Experience in identifying compliance gaps, writing, evaluating, and closing investigations with strong technical writing experience.
- Managing Projects and/or Operational Excellence experience is preferred.
- Excellent people leader with strong coaching and mentoring skills
- Excellent communication skills.
- Excellent problem solving and quality critical thinking.
- Ability to synthesize data and summarize outcomes to provide recommendations on a compliant path forward.
- Domestic and international travel might be required (up to 25%)
The level of this position will be based on the final candidate's qualifications. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
EQUAL OPPORTUNITY EMPLOYER
AavantiBio is committed to nondiscrimination with respect to race, creed, color, religion, age, disability, sex, sexual orientation, gender identity and expression, marital status, national origin, political opinions or affiliations, genetic information, and veteran status in all aspects of employment including recruitment, hiring, promotions, transfers, discipline, terminations, wage and salary administration, benefits, and training.
About the company
Biotechnology | 11-50 employees
AavantiBio is a clinical-stage biopharmaceutical company committed to developing and commercializing novel gene transfer and gene editing therapies for the treatment of rare and ultra-rare genetic diseases. The company is rapidly building a diverse portfolio of gene transfer and gene editing therapies to target debilitating genetic diseases for which the unmet medical need is high and for which there are typically no approved therapies treating the underlying disease. AavantiBio is headquartered in Cambridge, MA with additional locations in Gainesville, FL. We are looking for exceptional individuals who share our passion for developing novel therapies to treat rare diseases and advancing the field of gene transfer therapy. Developing genetic treatments for rare diseases is inspiring but challenging work and it takes dedication and courage which will make a meaningful impact on those who suffer from rare diseases. At AavantiBio, we will push each other to perform at our very best, and build a company that not only our employees are proud of, but also the rare disease community, because everyone knows we are trying to make a difference in patients’ lives. Come join our team!