Associate Director, Quality Compliance Corporate Audit Program/ Inspection Readiness
Associate Director, Quality Compliance Corporate Audit Program/ Inspection Readiness
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
The Associate Director, QA Compliance - Internal Audit / Affiliate Audits, will report to the Director of Corporate Audits / Inspection Readiness. This key position will lead inspection readiness activities Gilead Foster City PDM including inspection logistics management, building inspection readiness tools, providing training and partnering with key functional areas and teams to ensure perpetual readiness at GSI FC for general GMP/GDP inspections and preapproval inspections.Roles/Responsibilities:
- Manages the logistics to support regulatory inspections at GSI FC including notification process, inspection support team (IST), prep room and inspection rooms and post-inspection activities
- Build inspection readiness tools, templates and training materials for perpetual readiness for GSI FC - including inspection system training, inspection support team (host, scribe, request champion, SMEs, Facilities, IT etc.)
- Develop and maintenance of Inspection Readiness SharePoint as a centralized resource for inspection readiness support and resources for FC PDM Organization
- Lead global inspection readiness activities and meetings to share best practices and collaborate on inspection readiness topics and projects; identify and drive improvements
- Responsible for the management and maintenance of regulatory inspection procedures and documentation including Regulatory Inspection Policy, Site Master File, Opening Presentation and other related procedures
- Lead PAI readiness activities by partnering with project teams to evaluate inspection readiness of the team including coordination of a mock inspection as needed
- Lead periodic inspection readiness activities for GSI FC including annual mock inspection, inspection logistics drill, inspection readiness meeting with different function areas that will support and participate during an inspection (Management, Inspection Support Team, Security, Administrative Assistance, Facilities and IT)
- Provide logistics support for partner audits including training, inspection coordination and prep room support.
- Management of all inspection related documentation including document retention and tracking (pre-inspection notification, documents reviewed/retained/requested by investigator/agency)
- Management of post-inspection activities including upload of inspection documents in GTrack; coordination and assessment of inspection observation response from key stakeholders, maintenance of evidence binder and coordination of the inspection readiness of the evidence binders and/or storyboards
- Draft relevant procedures to assist in the overall management of inspections (receiving calls/inquiry from agency, site procedures for arrival of investigator, system related)
- Management of inspection systems utilized to support inspections including guides, tools, troubleshooting and training (i.e. MSTeams, Audit Utopia, Sharepoint, Zoom)
- Coordinate site inspection logistics with the different cross functional groups including general notification, investigator needs, conference room set-up (printers, boards, zoom, phones, office supplies, laptops, ipad/cart for virtual tours) and inspection support team assignment and schedule
- Act as liaison for regulatory inspection for GSI FC PDM inquiries (such as license renewal, manufacturer's questionnaire, drug manufacturing license etc.)
- Assume the key inspection roles of Inspection Champion, Prep Room Manager or Logistics Manager during regulatory inspections
- May support the other programs under Corporate Audit Program- internal audits, site audits, affiliate and 3PL audits, GMP walkthrough, as needed
- Other responsibilities as required
- Position may include travel (~up to 20%)
- Knowledge and practical application of domestic and global regulations including 21 CFR Parts 11, 210, 211, 600, 610, 820; EudraLex Volume 4 and applicable annexes; EU Good Distribution Practices for Medicinal Products and Health Canada GMP/GDP guidances; as well as ICH, ISO and USP / EP compendial standards
- Detailed knowledge of the manufacturing and testing processes associated with APIs, Oral Solid
- Drug Product, Liquid Formulations, Biologics, Aseptic Fill / Finish, Primary and Secondary Packaging, and Warehousing / Distribution
- Applies most current market regulations, functional trends, quality standards, and techniques to deliver high quality work
- Good leadership and organizational skills, ability to work independently, under minimal direction
- Strategic visionary and able to design well-written, well-organized, and professional documents and presentations including outputs and actions
- Effective communication skills within a matrix management environment (verbal, written and presentation)
- Team player with excellent intrapersonal skills and with the ability to work in a matrix organization
- In-depth knowledge of audit process and risk-based principles
- Well recognized as a knowledgeable and credible resource for QA compliance in other departments
- Excellent knowledge of computer systems; i.e. Microsoft Word, Excel, Powerpoint, MSTeams, Visio and TrackWise
- 10+ years of relevant experience in the pharmaceutical industry and a BS or BA OR 8+ years of relevant experience and a MS.
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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.
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