Manager, Quality Assurance

Location
Boston, MA, United States
Posted
Jul 28, 2021
Ref
94B53B2767
Hotbed
Genetown
Required Education
Bachelors Degree
Position Type
Full time
Manager, Quality Assurance

Location: USA

Reporting to: Associate Director Quality Assurance

Job summary

The Manager of GMP QA will report to the Associate Director, GMP QA and will be based remotely in the US. In this role, the incumbent is responsible providing quality support to assure that the manufacturing and testing operations at contract development manufacturing organizations (CDMO) are performed in compliance with ICH guidelines and applicable EU/US regulatory requirements.

The incumbent will engage with Cell and Gene Therapy Technologies, Quality Control, External Development and Supply Chain, CMC Lifecycle Management, Project Management, Regulatory, and other departments on a variety of activities. Such activities include QA oversight of technology transfer and on-going operations at CDMOs, supporting GMP qualification and routine audits at CDMOs, supporting batch disposition, providing oversight of internal quality records, and providing QA guidance to internal project teams. The incumbent will support Orchard's clinical and commercial products and provide QA expertise and project support to the Global GMP Quality team to develop and execute strategies to meet the team goals.

This an exciting opportunity for a well-qualified candidate to join a rapidly growing international company focused on transforming the lives of patients with rare disorders through innovative gene therapies.

Scope of responsibilities
  • Review and approve master batch records, master labelling/packaging records, product specifications and other process related documents from contract manufacturing sites
  • Perform batch record and data review/approval and manage process deviations for timely release
  • Perform batch release through batch record and data review/approval, and manage quality event closure for timely release.
  • Review and/or approve deviations, OOS, OOT, CAPAs, change control in an efficient manner for adequate and timely closeout of these events
  • Write and periodically review SOPs to further develop the Quality System and control over the quality of vendor services and products
  • Review and approve manufacturing and analytical validation protocols and reports
  • Review and approve Equipment Qualification and Software Validation documents, including but not limited to Risk Assessment, IQ/OQ/PQ protocols and reports
  • Review and approve product stability reports
  • As appropriate, attend project meetings and provide input to quality-related issues
  • Clearly communicate issues to vendors and Orchard's management in a timely basis
  • Support regulatory inspections; internal and external
  • Support activities at CDMOs ensuring compliance with cGMPs and Orchard's best practices
  • Support the technology transfer of late stage programs between CDMOs
  • Support the process performance qualification for late stage programs and continued process verification for commercial processes.
  • Assist in the development and tracking of Quality Metrics
  • Support the Material Review Board program

Leadership capabilities

Setting Strategy
  • Contributes to the goals for the QA function
  • Seeks and analyses data from a variety of sources to support decisions
  • Takes a creative approach to developing new and innovative ideas
  • Sets clear and challenging goals while committing the QA team to improved performance; tenacious and accountable in driving results
  • Comfortable with ambiguity and uncertainty; able to make decisions through complex situations
  • Makes good decisions regarding complex QA related issues
  • Demonstrates an aptitude for continuous improvement by being open to feedback and self-improvement
  • Creates collaborative and trusting relationships internally and externally
  • Celebrates and supports the success of the QA team

Executing for Results

Collaborations and Influence

Requirements

Qualifications
  • BSc or higher degree in biology, biochemistry or other relevant scientific discipline.
  • Extensive experience in the biotechnology, pharmaceutical or gene therapy
  • Experience with managing CDMOs and external vendors
  • Experience with technology transfer and process performance qualification is preferred
  • Experience of performing vendor audits
  • Experience working with Quality Systems (deviations, quality issues/events and related CAPAs) in support of clinical and commercial programs
  • Skilled in writing and reviewing SOPs and work instructions
  • Sound understanding and demonstrated application of root cause analysis tools
  • In depth working knowledge of cGMPs, ICH guidelines and applicable EU/US regulatory requirements for biological products.
  • Creative problem solver, with clearly demonstrated problem-solving skills
  • Well-organized and detail oriented with good verbal and written communication skills.
  • Ability to operate in a fast-paced, multi-disciplinary industrial environment
  • Self-motivated, assertive, and self-confident with the ability to act with urgency and passion.


    Orchard is an equal opportunity employer. We recognize and celebrate the diverse culture of our workforce and are committed to creating an inclusive environment for our employees. We fully support the principle of Equality and Diversity in employment and oppose all forms of unlawful or unfair discrimination. We assess all applications on basis of job requirements and individual qualifications.

    We work within the requirements of all current legislation and we implement the provisions of regulatory codes of practice in employment.

    Notice to All Applicants: Orchard Therapeutics participates in E-Verify