Associate Director, Quality & Compliance (Clinical)

Foster City
See job description.
October 10 2021
Position Type
Full Time
Organization Type
Job Type

Associate Director, Quality & Compliance (Clinical)
United Kingdom - UxbridgeUnited Kingdom - Cambridge

Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gileads therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

Making an impact on a global scale
Inclusion is one of the companys five core values. Thats because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.

When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible

Specific Responsibilities:

This is an exciting opportunity for an Associate Director, R&D Quality and Compliance. This role will be based in Stockley Park or Cambridge and will report to the Director Regulatory Compliance

Essential Functions:
  • Leads efforts to increase the commitment to quality in individuals and a culture of quality within the organisation.
  • Work is performed under consultative direction towards corporate and department goals and objectives. Ensures that tools are appropriate and fit for purpose.
  • Supervises the coordination of the work of others.
  • Ensures annual audits plans are developed and audit activities are completed according to plan.
  • Monitors resources and budget for audits.
  • Identifies new contract auditors, oversees the establishment of agreements and ensures all commitments are met by contract auditors.
  • Responsible for the oversight of SOPs evaluation and implementation.
  • Keeps a watch toward changes in industry/regulatory environment that would necessitate future changes and proactively initiates discussions so the company is prepared to respond to such changes.
  • Contributes to or leads intra- or interdepartmental teams of a strategic nature such as: defining the direction of the company in response to industry or regulatory initiatives, implementing company wide Quality Management or computer systems.
  • May lead management of regulatory agency inspections and coordination of responses to any regulatory agency findings.
  • Anticipating training requirements based on business needs and evolving regulatory environment.
  • May lead change projects which have strategic impact on the organisation.
  • Acts as a role model for change by demonstrating commitment.
  • Considers a number of factors in planning, anticipate work and prioritise work to meet tight timelines.
  • Direct others in prioritising their work.
  • Assists in developing strategic plans for business areas that contribute to organisational goal.
  • Contributes to establishing compliance quality standards.
  • Checks perspective of others and adapts communication approach accordingly.
  • Builds positive support for position outside of formal meetings.
  • Determines most efficient and appropriate method of communication in a variety of situations.
  • Understands impact of decisions and actions on business and consults with appropriate colleagues and management.
  • Promotes and maintains productive working relationships.
  • Mentors others in establishing good working relationships.
  • Addresses sensitive issues in an objective manner.
  • Must have a highly developed knowledge of regulatory requirements for assigned territories.
  • Is recognised as a knowledgeable resource within the department and from other departments on a range of topics and someone whose opinion is sought as a regulatory resource.
  • Understands current global and regional trends in regulatory compliance and has the ability to assess the impact of these requirements to the business.

Knowledge, Experience & Skills:

  • A BS or MS degree (or international equivalent)
  • Considerable relevant experience working in a pharmaceutical quality control, quality assurance or compliance environment

Equal Employment Opportunity (EEO)
It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual's gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.

For Current Gilead Employees and Contractors:

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