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Senior Director - Uxbridge, Greater London, United Kingdom - Gilead Sciences, Inc.
Description
Director - Quality Assurance page is loaded Director - Quality AssuranceBewerben locations United Kingdom - Uxbridge posted on Vor mehr als 30 Tagen ausgeschrieben job requisition id R
For Current Gilead Employees and Contractors:
For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe.
We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations.Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.
Join Gilead and help create possible, together.Director - Quality Assurance
The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, and cancer.
Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.We are currently seeking an industry leader for a Director, Quality Assurance role, who will report to Executive Director, Supplier Quality Management and Audits, within the Global Quality Systems & Compliance department.
The role is highly visible, offer tremendous growth potential, and requires technical acumen, strong leadership, and collaboration with cross-functional stakeholders across QA, Global Supply Chain, Manufacturing Operations and Technical Development.
Primarily conduct global vendor audits for contract manufacturing of Gilead BiologicsSupport and/or conduct audits of providers of raw materials, product contact consumables, contract manufacturing or testing, software, warehouse / distribution in support of Gilead's clinical and commercial oral and parenteral dosage formulations and associated medical devices as assigned.
Manage all aspects of the audit lifecycle including scheduling, planning, issuing agendas, executing, issuing reports, evaluating responses, requesting clarification, issuing CA/PA, and closing.
Align, strategize and collaborate with the Global Supplier Quality function within GileadEnhance Global Third party Quality Oversight program and Qualification Process by leading initiatives to maintain compliance to global regulations and standards
Represent the Quality function in by developing the program and supporting the selection process for new/preferred suppliers
Act as liaison between global supplier quality and Gilead's production facilities
Ensure that the audit agenda is risk-based and has the appropriate internal and/or external subject matter experts as part of the audit team.
Participate in the development, implementation, and maintenance of procedures and templates to assist in the evaluation of and in improvement of the auditing process.
Identify compliance risks and escalate issues to appropriate levels of management for resolution.Promote, awareness across the biologics commercial and clinical manufacturing platform(s) of current regulatory agency requirements and trends and develop and report on the trends identified to better focus the scope of audits.
Drive consistency with audit report observation writing, classification, status, and overall riskTravel may be required up to 40%
Regulatory Intelligence
~ Effectively communicate regulatory trends, insights and implications for Gilead to senior leadership with presentations and written reports
~ Respond to queries from internal stakeholders to support inspection readiness, external audits, regulatory submissions and staff training
~ Maintain online platforms (e.g., SharePoint) to provide intelligence related to Gilead's products, internal and external manufacturing and testing sites
~ Significant relevant experience and a Bachelor's degree in science or related fields, MS, MD, PharmD, PhD or an advanced business degree such as an MBA.
Manufacturing, Quality Control, Quality Assurance)
Knowledge of domestic and international regulations including 21 CFR Parts 11, 203, 205. Deep knowledge and experience in quality assurance in a highly regulated manufacturing environment.
Biopharmaceutical or Pharmaceutical experience preferred.
Broad experience across areas like CMO QA, Validation, Drug development experience and/or Pharmacovigilance and understanding of Parenteral, Aseptic and API operations is beneficial
Everyone at Gilead is motivated by our overarching mission to discover and deliver innovative therapies that improve patient care in areas of unmet medical needs.
Inclusion (encouraging diversity)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).For Current Gilead Employees and Contractors:
Associate Director, Quality Assurance Compliance/Auditor
locations United Kingdom - Uxbridge time type Full time posted on Vor 3 Tagen ausgeschrieben Gilead Sciences, Inc.
is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people.
The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer.
Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.#
