Head of Quality

Posted Date:03-May-2023

Location:
Penicuik, GB, EH26 0BF

Company:
Quotient

We are recruiting a
_Head of Quality_ to join our ARC site based near Penicuik (EH26 0BF). The role is a full-time, permanent position, working 37.5 hours per week, Monday to Friday.

The Head of Quality is responsible for all Quality operations within Quotient UK, acting as a member of the Regulatory and Management teams, contributing to the strategic development and management of the Quality function.

With an expert knowledge of international regulatory and Quality standards, the individual develops and maintains relationships with regulatory and licensing bodies to ensure that Quotient continues to achieve the highest international quality standards.

JOB DESCRIPTION

The main responsibilities will include:

• Serving as a member of the Regulatory and Quality Management team for oversight and guidance of the entire organization on RA and QA strategy and activities
• Developing, managing and coordinating the operative Quality activities of the business that will deliver continued compliance with GMP and documented Quality Systems thus enabling the unit to comply with applicable legislation and FDA Regulations.
• Participating as a member of the Functional Management team in the formulation, implementation and review of strategic and business plans for the functions.
• Participating in Operational and Management teams and assists with the implementation of agreed policy and objectives to ensure the efficient and effective operation of the Business.
• Promoting a culture of Quality awareness, GMP, customer satisfaction and continuous improvement. Driving continuous improvements through best practice, including adoption of Six Sigma & Lean philosophies.
• Ensuring that all procedures are fully documented in line with local, national and international policies.
• Managing a program of premises, equipment and process validation to ensure procedures are accurate, reproducible, valid and comply to specifications.
• Ensuring effectiveness & delivery of routine quality system functions, including QC testing, auditing (internal & external), GMP compliance and documentary control

QUALIFICATIONS, EXPERIENCE & BEHAVIOURS REQUIRED

• Degree or an equivalent Life Sciences qualification
• Postgraduate Quality Management qualification (desirable)
• Expert knowledge and practical experience of CE and FDA regulations, in a manufacturing environment.
• Recent practical experience of implementing Quality and Regulatory compliance systems within an FDA licensed manufacturing facility
• Significant senior management experience
• Knowledge of the IVD market and specific knowledge of Immunohaematology products (desirable)
• Effective business and interpersonal skills to build relationships with all stakeholders.
• Effective communication skills, requiring interaction and presentations to a wide range of international customers and cultures and at all organisational levels

ADDITIONAL INFORMATION

• Competitive salary on offer
• Quotient offer a range of core and flexible benefits ranging from private medical cover, life assurance, additional annual leave, cycle to work, technology, experience days and access to marketplace discounts.

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