Reporting to the Director of Quality, the Head of Quality Assurance manages quality and compliance-related responsibilities for Andelyn Quality Assurance and Andelyn-sponsored manufacturing activities with respect to relevant Standard Operating Procedures, applicable Regulatory requirements, and current industry standards and practices. Oversees the development, implementation and maintenance of both Corporate and GMP/GLP quality assurance systems and activities. 

What Will You Be Doing?

  • Leads and directs the implementation of QA policies and procedures to ensure cohesive and consistent quality plans are executed (includes Quality systems, cGMP/GLP, and other regulatory standards as applicable)
  • Develops and implements the overall quality strategy for the facility.
  • Partners with the Site Director and Senior Leadership Team to ensure alignment with Manufacturing and support functions in executing the strategy.
  • Acts as the lead SME for significant quality/compliance issues within the asset.
  • Manages the asset QA budget and resources to maximize efficiency and maintain quality/compliance at high levels.
  • Develops, directs, and maintains quality systems in support of manufacturing in a manner consistent with global quality systems, Andelyn requirements and standards and current regulatory requirements, (primarily US FDA and European requirements) and others as needed.
  • Quality systems include but are not limited to audits and inspections, documentation and records management.
  • Interfaces with site QA functions for equipment, facility, cleaning and computer validation/qualification and the site-based QA systems.
  • Oversees all aspects of QA operations within the facility, including but not limited to batch record review, on-the-floor QA support, deviation investigations, change controls, Quality agreements, and SOP and master batch record review.
  • Responsible for release of clinical and commercial batches.
  • Ensures QA support for internal and external project and team meetings.
  • For significant issues, interfaces with customers and internal groups for resolution of quality issues.
  • Has decision-making authority for all asset Quality issues; informs Site QA Head of critical issues in a timely manner.
  • Builds and maintains expertise in the asset QA team, ensuring development of staff.
  • Applies quality/manufacturing experience, including process validation, to ensure that operations meet customer and regulatory expectations.

 

What Are We Looking For?

  • Bachelor’s degree in life sciences or engineering
  • Bachelor's Degree, Preferred area of study: Life sciences or Engineering
  • Substantial experience in a biopharmaceutical manufacturing experience and/or quality operations or quality systems working in a GMP environment.
  • Prior experience in biologics API or drug product Quality Assurance is required; experience in mammalian cell-derived biologics is desired, but not essential.
  • A strong foundation in application of GMPs in a drug substance or drug product manufacturing environment is critical
  • Ability to quickly assess facts and make the appropriate decision when process/product quality may be impacted.
  • Significant experience in managing people in a Quality Assurance role.
  • Strong knowledge in the application of cGMP requirements to biologics manufacturing processes, and purpose and function of supporting processes.
  • Ability to apply cGMPs in a biologics manufacturing environment in a compliant and pragmatic manner.
  • Understanding of facility design requirements and operating principles for biologics manufacturing.
  • Understanding of validation/qualification principles, industry practices, and standards with ability to apply these to GMP operations as a QA leader.
  • Working knowledge of all Quality Systems required for a biologics manufacturing facility.
  • Demonstrated ability to oversee GMP operations, make sound decisions regarding evaluation of GMP compliance, and leadership abilities in the management of QA activities.
  • Effectively presents information and ideas formally and informally, verbally and in writing to others in a manner that facilitates understanding.
  • Able to communicate status, needs, forecasts, risks and timelines effectively to management.
  • Displays a clear willingness to listen to others.
  • Has good interpersonal skills and works inter-departmentally in an effective manner to achieve objectives.
  • Shows commitment and dedication and strives to be ahead of schedule.

 

Minimum Physical Requirements:

  • Sitting for extended periods Constantly (67-100%)
  • Talking on the phone/in person Constantly (67-100%)
  • Typing on a computer keyboard Constantly (67-100%)
  • Standing/walking Occasionally (0-33%)


EOE M/F/Disability/Vet

 


Andelyn Biosciences is currently operating under Executive Order 14042 that requires that employees of federal contractors and its affiliates be vaccinated against COVID-19, with some limited exemptions under the law.  As Andelyn is both an affiliate and will be a federal contractor, proof of vaccination status will be required prior to first date of employment.  Religious and medical exemptions may be considered depending upon the specific job duties and in accordance with applicable federal guidelines.

 

 

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