Sr. Manager, Quality Systems - Global Product Complaints

Sr. Manager, Quality Systems - Global Product Complaints
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. Gilead's 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 company's five core values. That's 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

Sr. Manager, Quality Systems - Global Product Complaints

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 strong 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.

Working in Quality Assurance (QA) at Gilead:

Quality Assurance delivers on Gilead's commitment to bring life-changing therapies to patients through the robust QA processes and systems. Our approach is agile, innovative and collaborative and our teams are genuinely committed to the rapid delivery of safe life changing therapies.

Job Summary:

Gilead Sciences is currently seeking a Senior Manager, Commercial Quality - Quality Systems, 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. Specifically, this role will lead the commercial complaint function in QA

Essential Duties and Job Functions:

• Manages global clinical and commercial compliant management process.
• 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 complaints across all Gilead Sciences sites and presents data periodically for Quality Management Review.
• Leads and co-ordinates complex complaint 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 to develop strong leaders.
• Responsible for supporting the Field Alert Process and escalation activities, leading critical product investigations that may impact multiple sites across the Gilead network and driving to closure, ensuring adequate CAPAs are implemented where appropriate.
• 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.

Basic Qualifications:

Bachelors' degree AND 8+ years of relevant experience in the pharmaceutical industry

OR

Master's degree AND 6+ years of relevant experience

Knowledge, Experience and Skills:

• 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 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.
• Knowledge and experience in quality assurance in a highly regulated manufacturing environment.
• Professional presence and diplomatic approach are 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 Manager) or other industry- recognized professional organizations.

To apply, please submit resume through our website at www.gilead.com

Gilead is an equal opportunity employer.
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 careers@gilead.com for assistance.

For more information about equal employment opportunity protections, please view the 'EEO is the Law' poster.

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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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