Senior Manager, Quality Assurance
Senior Manager, Quality Assurance
Ireland - Cork
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
- Ensures quality oversight of commercial and/or development products at CMOs
- Oversees the commercial and/or development implementation of the Quality strategy for Gilead development portfolio of products and/or across quality sub-functions
- Partners with Development, Manufacturing, Supply Chain, Outsourcing and Drug Substance to deliver on development programs
- Ensures that performance and quality of drug products conform to established standards and regulatory agency requirements.
- Assure CMO's meet Gilead's quality, regulatory and compliance standards, in order to ensure a sustainable delivery of quality product to patients and maintain a good working relationship
- Reviews regulatory documents and provides expertise and guidance in interpreting governmental regulations, agency guidelines and internal policies to assure continued compliance. Participates in regulatory authority inspections
- Collaborates, engages and works cross-functionally with other Quality groups
- Acts as an escalation contact for complex and high impact quality issues, concerns and decisions.
- Leads/coordinates investigations, and the development and implementation of corrective and preventative action (CAPA)
- Quality Risk Management, identifying key risks impacting commercial and development programs
- Competent in execution and responsible for translating quality strategy into plans of action.
- Anticipates shifts in industry trends and regulatory environment that will impact Gilead's business needs and positions the function to respond accordingly.
- Participates in developing controlled documents (e.g SOP's, validation, etc.)
Knowledge & Skills:
- Demonstrates understanding and application of GMP principles, concepts, best practices and standards in the US and internationally.
- Ability to develop and improve complex concepts, techniques, and standards and new applications based on quality principles and theories.
- Demonstrates strong knowledge of aseptic processing, solid dose and general pharmaceutical manufacturing.
- Ability to provide guidance to solving problems, uses Gilead Quality standards, regulations and industry practices.
- Demonstrates extensive knowledge of industry best practices and trends.
- Demonstrates excellent verbal, written, and interpersonal communication skills.
- Is comfortable interacting with regulatory agencies as needed.
- Demonstrates the ability to manage staff.
- Participates in compliance audit as required
Education & Experience:
- Significant years of relevant experience and a Bachelor's degree in science or related fields or advanced science degree such as MS, MD, PharmD, PhD or an advanced business degree such as an MBA.
- Prior people management experience is beneficial.
- Knowledge and experience in quality assurance in a highly regulated manufacturing environment.
- Biopharmaceutical and/or Pharmaceutical experience preferred.
- Broad experience across areas like CMO QA, Validation, Drug development experience and/or Pharmacovigilance, understanding of Parenteral and Aseptic processing. OSD and Biopharmaceutical operations is beneficial.
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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