Senior Director, Quality
Senior Director, Quality
United States Remote
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
Senior Director, Quality
- Leads the development parenteral drug product quality organization at Foster City and Contract Manufacturing Organizations (CMO)
- Ensures quality oversight of commercial and/or development products at CMOs
- Oversees the commercial and/or development and implementation of 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
- Develops, establishes and maintains quality assurance programs and systems, policies, processes, procedures and controls ensuring 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 and approves regulatory documents and provides expertise and guidance in interpreting governmental regulations, agency guidelines and internal policies to assure continued compliance. Leads preparations for and participates in regulatory authority inspections
- Key strategic member of Quality Assurance Parenteral management team, collaborates, engages and works cross-functionally with other Quality groups
- Provides leadership and builds a highly capable team through the attraction, training and development of the necessary skilled professionals to meet business needs.
- Manages tactical and strategic operations of parenteral DP with responsibility for performance evaluations, staff development, training and succession planning
- 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 development programs
- Competent in both strategy and 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.
Knowledge & Skills:
- Demonstrates in-depth understanding and application of GMP principles, concepts, best practices and standards in the US and internationally.
- Is able 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.
- Is able to develop solutions to complex problems, which require a high degree of ingenuity, creativity and innovativeness, and where precedent may not exist.
- 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 and possesses the ability to represent Gilead in public forums.
- Demonstrates experience and ability to manage staff.
- Is an experienced auditor with demonstrated acumen in resolving challenging audit situations.
Typical Education & Experience:
- 12 - 15 years of relevant experience and a Bachelor's degree in science or related fields.
- 8+ years of relevant experience and an advanced science degree such as MS, MD, PharmD, PhD or an advanced business degree such as an MBA.
- Prior people management experience.
- 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, understanding of Parenteral and Aseptic processing. Biopharmaceutical operations is beneficial.
For jobs in the United States:
As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans\' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact firstname.lastname@example.org for assistance.
Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all U.S. employees and contractors to receive the COVID-19 vaccines as a condition of employment. Full vaccination is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.\u200b
For more information about equal employment opportunity protections, please view the EEO is the Law' poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
PAY TRANSPARENCY NONDISCRIMINATION PROVISION
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
For Current Gilead Employees and Contractors:
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