Director, Quality Assurance
Director, Quality Assurance
United States - California - Foster City
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
Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.
Role and Responsibilities:
Gilead is seeking a Quality Assurance professional with key leadership responsibilities in managing Development and Commercial Quality Assurance (DCQA) activities within Gilead's Pharmaceutical Development and Manufacturing organization. The role leads, in a matrix organization, a team supporting API, Oral Solid Dose, Parenteral and Medical Device products in various clinical phases as well as commercial. Accountable for implementing quality standards and practices within a multinational organization, providing direct quality management oversight of global third party contract manufacturers/labs/packagers. Demonstrated success in leading and developing teams is critical to the success of this role.
Essential Duties and Job Functions:
- Accountable for tactical and strategic operations of the DCQA team with responsibility for performance evaluations, staff development and training,
- establishing/maintaining collaborative working relationships with CxO sites
- Fosters an effective working relationship with all internal team members and external partners.
- 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.
- Reviews and approves regulatory documents, specifications, SOPs/QAGs/APQRs and provides expertise and guidance in interpreting governmental regulations, agency guidelines and internal policies to assure continued compliance.
- Represents Gilead, as required, to authorities and regulatory inspectorates during CxO inspections. Assists in CxO inspection readiness preparations.
- Directs and manages the implementation of key development and commercial quality programs/initiatives; determines measures for success (metrics); and acts as an escalation contact for complex and high impact quality issues, concerns and decisions.
- Works collaboratively with commercial and development product manufacturing teams, business partners and CxOs.
- Point of contact for cross-functional integration of inputs and ideas, collaborating globally to solve problems.
- Champions Quality Risk Management, identifying key risks impacting commercial or development products for input into the global risk register.
- Leads, collaborates, and engages team members within DCQA and across the Gilead network to ensure Quality product is delivered to our patients in a timely, efficient and effective manner.
- Partners to build open communication and feedback channels for team, leaders, and peers.
- Provides leadership and operational excellence to enable the Quality function to work effectively in a development and commercial environment, including the appropriate allocation of resources.
- Leads/coordinates investigations, and the development and implementation of corrective and preventative action (CAPA) recommendations related to distribution activities.
Knowledge, Experience and Skills:
- Demonstrates experience and ability to inspire and lead, manage and develop staff.
- Demonstrates in-depth understanding and application of GMP principles, concepts, practices and standards in the US and internationally, as appropriate to the product life cycle phase.
- Demonstrates strong knowledge of aseptic processing, solid dose and general pharmaceutical manufacturing.
- Demonstrates substantial knowledge of industry best practices and trends.
- Demonstrates excellent verbal, written, and interpersonal communication skills.
- Is comfortable interacting with regulatory agencies as needed and possess the ability to represent Gilead in public forums.
- Strong collaborator across the organization and at all levels.
- Is an experienced auditor with demonstrated acumen in resolving challenging audit situations.
- 10+ years of relevant experience and a Bachelor's degree in science or related fields OR 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.
- Deep knowledge and experience in quality assurance in a highly regulated manufacturing environment.
- Prior people management experience.
- Broad experience across areas like CMO QA, Validation, Drug development experience and/or Pharmacovigilance and understanding of Parenteral, Aseptic and API operations is beneficial.
- Biopharmaceutical or Pharmaceutical experience preferred.
If this is not the right move for you now but remain interested in a career at Gilead Sciences please connect with us via our talent community: https://gilead.avature.net/Gilead
Gilead Sciences, Inc. is a research-based biopharmaceutical 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. Gilead's therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
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 email@example.com for assistance.
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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