Covance Associate Director - GMP Quality Assurance in Harrogate, United Kingdom

Job Overview

Associate Director – GMP Quality Assurance

COVANCE is a leading global drug development services company and we provide support to the Pharmaceutical and Biotechnology industries.

We are looking for an experienced Associate Director to lead our GMP Quality Assurance department in Harrogate on a full time, permanent basis. You will be working with an experienced team of approximately 20 people over 3 sites: Harrogate, York and Leeds.

About the Job

Within this position, your duties will include:

  • As a member of the Global GMP QA Management Team, contributing to the development and continual improvement of the GMP Quality Management System (QMS) and supporting strategies aimed at achieving and maintaining regulatory compliance

  • Leading the site/regional implementation of the global GMP QMS, ensuring local requirements and Regulatory Authority / Client expectations are addressed locally/regionally

  • Managerial responsibility for the site/regional GMP QA organization; including workload and resource assessment, recruitment, performance evaluation, professional and personal training and development, implementation and follow-up of departmental objectives, etc.

  • Providing regulatory expertise, leadership, consultation/arbitration and independent review both internally and to Clients on aspects of quality and GMP compliance

  • Sets site/regional GMP quality objectives and monitors appropriate performance metrics and data trends to facilitate improved compliance and efficiency of GMP QA activities

  • Ensuring effective regulatory review and approval of policies, procedures and study/project related documentation

  • Implementing/maintaining a risk-based programme of internal system, process and facility-based audits

  • Ensuring a programme of GMP training is developed and delivered to GMP QA and relevant Operational Personnel

  • Providing QA support to ensures facilities, utilities, equipment and computer systems are appropriately validated/qualified and the integrity of data is assured

  • Leading the site/region Management Review Process, ensuring necessary corrective actions and/or process improvements are implemented Primary point of contact for regulatory authorities and clients on subjects related to GMP compliance

  • On Phase 1 Pharmacy sites, ensuring the QA batch review and release/rejection of Investigational Medicinal Product (IMP).

What we’re looking for

  • To be successful in this position, you will need to hold a Bachelors Degree in a Pharmacy, Chemistry or Biology related discipline

  • Postgraduate degree (MSC or equivalent) in science-related discipline desirable

  • Management qualification/certification, e.g. MBA (may be substituted by significant management experience)

  • Eligible to be named as a Qualified Person on the MIA(IMP) preferred

Additionally, you will need to demonstrate:

  • Excellent interpersonal and organizational skills, e.g. communication, negotiation, critical thinking, problem solving, risk-based decision making

  • Proven leadership and people management

  • Previous experience in a client facing role

  • A minimum of 8 years’ experience in a GXP regulated environment, preferably in a QA/GMP role in the pharmaceutical or related industry; at least 2 years in a management role

  • In depth knowledge of Good Manufacturing Practice Regulations and other related industry quality standards (e.g. ICHQ10, ISO 9000)

  • Computer Literate

Get to know Covance

Covance, the drug development business of LabCorp, is the world’s most comprehensive drug development services company. Because of our broad experience, from early research to commercialization, our more than 20,000 employees from across the globe are in a unique position to supply insights that go above and beyond testing. Our team’s impact on healthcare is remarkable. Through their everyday work they’ve supported 100% of the top 50 drugs on the market and all the oncology drugs approved in 2016. Even though we span multiple businesses, we operate as one, sharing our knowledge to improve our efficiency and deliver on the promise of a healthier world.

The Covance team is driven by an energized purpose to improve health and improve lives across the globe. Here, you’ll work alongside exceptional people who each play an important role in bringing new scientific discoveries and therapeutic area advancements to life. And, because we span the drug development spectrum, you’ll directly impact a wide-range of initiatives as you explore unique career paths and discover your extraordinary potential.

Get ready to make a difference as we speed the delivery of groundbreaking therapies and improve lives of countless individuals.

EEO Statement

Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.

For more information please contact

Or apply directly on careers.covance.com with reference 19668

Education / Qualifications

Typical Qualifications Required:

  • Bachelors Degree in a Pharmacy, Chemistry or Biology related discipline

  • Postgraduate degree (MSC or equivalent) in science-related discipline

  • Management qualification/certification, e.g. MBA (may be substituted by significant management experience)

  • Eligible to be named as a Qualified Person on the MIA(IMP) preferred

Note: the above qualifications may be substituted with relevant experience

Experience

  • Excellent interpersonal and organizational skills, e.g. communication, negotiation, critical thinking, problem solving, risk-based decision making

  • Proven leadership and people management

  • Previous experience in a client facing role; able to interact effectively with clients and regulatory authorities

  • A minimum of 8 years’ experience in a GXP regulated environment, preferably in a QA/GMP role in the pharmaceutical or related industry; at least 2 years in a management role

  • In depth knowledge of Good Manufacturing Practice Regulations and other related industry quality standards (e.g. ICHQ10, ISO 9000) preferable

  • Experience leading strategic process improvement initiatives

  • Computer Literate

Job Number 2018-19668

Job Category Quality Assurance

Position Type Full-Time

Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.