Associate Director, Quality Assurance
Associate 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 Sciences is currently seeking an Associate Director, Quality Assurance, in the Pharmaceutical Manufacturing and Development (PDM) organization located in Foster City, CA. The role is responsible for the administration of quality standards and practices within a multi-national organization. This Quality professional will be a strategic leader in a cross-functional management team.
*Strong preference for the candidate to be based out of Foster City Location however would also consider candidates to work out of San Dimas/La Verne, CA location.
- Provides leadership and direction in quality systems and continuous improvement initiatives for commercial drug product and serves as a quality expert in GMP standards, policies, guidelines and procedures
- Manages tracking and trending of quality issues across all Gilead Sciences sites and presents data periodically for Quality Management Review
- Leads and co-ordinates complex investigations, including development and implementation of corrective actions
- Interfaces with regulatory agencies as required, representing Gilead to authorities and regulatory inspectorates. Prepares and presents data to the regulatory agency during inspections
- Writes and/or implements changes to controlled documents (e.g., SOPs, investigational protocols etc.) as needed
- Manages QA personnel, including organizing and prioritizing daily tasks, performing training, and writing performance reviews.
- Provides leadership and operational excellence to enable the Quality Systems team to work effectively, including the appropriate allocation of resources
- Lead and /or participate on global quality systems project teams. Serve as a point of contact for enhancements or future integrations
- Reviews and approves training programs regarding implementation of quality systems
- Develops an effective working relationship with Gilead sites, CMOs and marketing clients
- Supports development and implementation of strategic Quality assurance programs and initiatives
- Serves as role model for strong people and project leadership through actions, decisions and directing others in an effort to develop strong leaders
- Lead/participate in external commercial quality audits; hosting internal audits by license partners and support CMO site inspections by regulatory agencies
- Lead cross-functional improvement projects and promote a culture of quality
Essential Duties and Job Functions:
- Responsible for critical issue management (escalation of quality issues, health authority notifications and product actions)
- Responsible for drafting and submitting Field Alert Reports, Drug Notifications, Biological Product Deviation Reports.
- Lead Recall activities and conduct mock recalls
- Lead critical product investigations that may impact multiple sites across the Gilead network and driving to closure, ensuring adequate CAPAs are implemented where appropriate
- Manages global clinical and commercial compliant management process
Knowledge, Experience and Skills:
- Must have strong knowledge of CGMP (FDA, EU and ICH) requirements, FDA/EU regulatory guidelines, validation practices, Quality and Compliance principles.
- Demonstrates in-depth knowledge of QA principles, concepts, industry practices, and standards.
- Demonstrates strong knowledge of solid dose, combination products and general pharmaceutical manufacturing.
- Exercises judgment within defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
- Demonstrates substantial knowledge of industry best practices and trends.
- Excellent attention to detail, and ability to consistently meet high standards required in Compliance.
- Demonstrates excellent verbal, written and interpersonal communication skills.
- Professional presence and diplomatic approach is instrumental in the success of this position
- Demonstrates knowledge of Six Sigma, Define-Measure-Analyze- Improve-Control (DMAIC) methodology, performance measures and quality improvement statistical
- Demonstrates working knowledge of Risk Management tools (e.g., Hazard Analysis and Critical Control Points (HACCP) and / or Failure Mode Effects Analysis (FMEA)).
- Certification by ASQ (Certified Quality Auditor, Certified Quality Engineer, and Certified Quality GMP Professional or other industry- recognized professional organizations
- 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.
- Knowledge and experience in quality assurance in a highly regulated manufacturing environment.
- Prior people management experience.
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 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.
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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