Senior Manager, QA - Combination Products
Senior Manager, QA - Combination Products
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
Senior Manager, QA Combination Products
- Provide QA oversight for all stages of the Design Control process according to FDA 21 CFR Part 820.30, ISO 13485, and Gilead quality system requirements.
- Interface with internal stakeholders and contract manufacturers to address and resolve complex technical drug-device combination product, process, and quality issues. Acts as an escalation contact for complex and high impact quality issues, concerns and decisions.
- Lead strategic relationships with internal cross-functional teams as well as related CMOs, including development of quality agreements.
- Provide risk management guidance to product development teams and support implementation of risk management strategies.
- Create and provide QA training as needed for cross-functional stakeholders and CMOs.
- Create and establish the annual internal audit standards and schedules for combination product lines.
- Provide guidance and impact assessments for Change Control, including DHF/RMF assessments.
- Write and/or implement changes to controlled documents (e.g., SOPs, specifications, test methods, etc.).
- Oversees the commercial and/or development implementation of the Quality device strategy for Gilead portfolio of products
- Ensures that performance and quality of combination products conform to established standards and regulatory agency requirements.
- 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
- Leads/coordinates investigations, and the development and implementation of corrective and preventative action (CAPA)
- Anticipates shifts in industry trends and regulatory environment that will impact Gilead's business needs and positions the function to respond accordingly.
- Interface with contract manufacturers to address and resolve drug-device related product/process performance issues.
- Collaborate with R&D during new combination product development and provide input into the design controls process.
- Work extensively with operating entities to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis.
- Participate in annual product reviews and assess changes and product complaints against the DHF and RMF.
Knowledge & Skills:
- Demonstrates understanding and application of QSR/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 medical devices, combination products and general pharmaceutical manufacturing.
- Is able to provide guidance to solving problems, uses Gilead Quality standards, regulations and industry best 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
Typical Education & Experience:
- 8+ years of relevant experience and a Bachelor's degree in science or related fields OR 6+ 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 is beneficial.
- Knowledge and experience in quality assurance in a highly regulated manufacturing environment.
- Previous experience with combination products is required, such as autoinjectors, co-packed kits, pre-filled syringes.
- QA experience in both clinical and commercial combination products.
- Strong project management and process improvement skills.
- Demonstrates keen understanding of domestic and internal quality systems regulations to adopt best in class systems/processes and drive continuous improvement initiatives.
- Knowledge of Six Sigma, Define-Measure-Analyze-Improve-Control (DMAIC) methodology, performance measures and quality improvement statistics is preferred.
- Experience with Risk Management principles according to ISO 14971, including the use of risk management tools such as FMEA.
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.
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