Senior Manager, Quality Assurance

Location
London, United Kingdom
Posted
Apr 30, 2021
Ref
3A092DA0D8
Required Education
Bachelors Degree
Position Type
Full time
Senior Manager, Quality Assurance

Location: London (UK)

Reporting to: Director Quality Assurance

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Job summary

We are seeking an enthusiastic, highly motivated, and team-oriented individual for the newly established position of Senior Manager, QA reporting directly to the Director of Quality Assurance. The role will be based in the UK London office. In this role, the incumbent is responsible for providing quality assurance oversight to ensure that manufacturing and testing operations at the contract organizations 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 Manufacturing and Development, 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, performing 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.

Key Elements and Responsibilities
  • Review and approve master batch records, master labeling/packaging records, product specifications and other process related documents from contract sites.
  • Perform batch release through batch record and data review/approval and managing process deviations for timely release.
  • Review and/or approve deviations, OOS, CAPAs, change control in an efficient manner for adequate and timely closeout of these events.
  • Write, revise, and periodically review SOPs to further develop the Quality System and control over the quality of vendor services and products.
  • Review and approve manufacturing validation protocols and reports.
  • Manages product recalls and complaint investigations.
  • Assist in the development and tracking of Quality metrics. Prepare metrics for the Management Review and Annual Product Review.
  • Review and approve of product stability reports.
  • As appropriate, attend project meetings and provide quality input and lead the resolution of quality-related issues.
  • Clearly communicate issues to vendors and Orchard Therapeutics management in a timely basis.
  • Supports the preparation, coordination, and management of regulatory agency Preapproval or regular inspections (internal and external).
  • Creates and articulates an inspiring vision and contributes to the goals for GMP QA; collaborates cross-functionally on the broader Quality strategy
  • Seeks and analyses data from a variety of sources to support decisions
  • Takes a creative approach to developing new, innovative ideas that will optimize and challenge the status quo to reach better GMP QA processes
  • Sets clear and challenging goals while committing the GMP QA team to improved performance, tenacious and accountable in driving results
  • Makes good decisions regarding complex QA related issues and communicates decisions effectively with internal stakeholders


Requirements

Required knowledge
  • Working knowledge of EU CGMPs; knowledge of US cGMP is an advantage
  • Extensive experience in the pharmaceutical/bio-pharm manufacturing industry with prior experience at the QA Manager level
  • Experience working with Quality systems in support of both early and late stage development programs.
  • Relevant equivalent content experience, including managing contract manufacturers and external vendors
  • Experience of performing vendor audits and implementing CAPAs preferred
  • Sound understanding and demonstrated application of root cause analysis and investigational tools
  • In depth working knowledge of cGMPs, ICH guidelines and applicable EU/US regulatory requirements for biological products.

Skills & Abilities
  • Strong technical/analytical skills to identify and solve problems.
  • Self-motivated, assertive, and self-confident with the ability to act with urgency and passion.
  • Proven ability to work with a high level of integrity, accuracy, and attention to detail.
  • Strong organizational skills in order to maintain a high level of productivity, innovation, and priority-setting in order to complete assignments on-time and on-budget.
  • Excellent oral and written communication skills for effectively interfacing with all levels of management and departments within the company.
  • Creates collaborative and trusting relationships internally and externally
  • Ability to make thoughtful, integrated, timely and meaningful decisions and take corresponding actions.
  • Willingness to work collaboratively by incorporating diverse perspectives and appropriately managing relationships in order to strength decision-making.
  • Proactively seeks out and recommends process improvements.
  • Resourceful, creative, enthusiastic, and results oriented.
  • Entrepreneurial, enjoys working in a fast-paced, small-company environment.
  • Creative problem solver, with clearly demonstrated problem-solving skills
  • Demonstrates an aptitude for continuous improvement by being open to feedback and self-improvement

Education
  • BSc or higher degree in biology, biochemistry or other relevant scientific discipline.


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.

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