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:
• Provides leadership and direction for quality and compliance activities related to a clinical or commercial Gilead product/program.
• Responsible and accountable for reviewing and approving: CXO product-impacting critical investigations, supply chain tables, bulk hold time studies/protocols/reports, ADME batch records/protocols/reports, process validation sampling plans, product-impacting Gilead change controls, API and DP specifications, and part numbers.
• Reviews regulatory filings, supports technology transfers, and participates in program/project reviews.
• Supports Gilead PAI inspection preparation efforts and post-PAI follow up with CXO/s and GCP audits/inspections at clinic sites.
• Participates in drafting commercial APQRs (Annual Product Quality Review) and reviews/approves Gilead and CMO APQRs for commercial products.
• Accountable for supporting the following: new product launches, health authority requests, product complaints, label review and approval, DP and API process validation.
• Ensures risks are identified, assessed and mitigated.
•Accountable for making sure issues are properly escalated for visibility and endorsement of actions.
• Represents quality assurance in CMC Teams and/or PDM Sub teams.
• Leads a sub-team of Quality professionals supporting the product/program and ensures visibility and communication of key project timelines and CMC milestones.
• Acts in a project manager capacity to ensure:, change controls, deviations or other issues, lab investigations, lot release status, test methods, method transfer and transfer status, stability studies, risks, metrics, regulatory inspections, audits, and other associated activities related to the product/program are accounted for and managed to timely completion.
• Supports opportunities for efficiency and capacity improvements to products/programs.
• Performs work that consistently requires independent decision making and the exercise of independent judgment and discretion.
• Serves as QA support in complex quality investigations/deviations/clinical compliant investigations.
• Assist in departmental planning activities to ensure that deliverables are provided according to project timelines
• Manages QA personnel, including organizing and prioritizing daily tasks, performing training, and writing performance reviews.
• Accountable for final release of manufactured products.
• Works with key stakeholders and/or contract manufacturers to address and resolve product/process performance issues and ensure that products are manufactured in accordance with established procedures, cGMPs, and appropriate regulations.
• Supports inspections and audits.
• May interface with regulatory agencies as required.Essential Duties and Job Functions:
- Performs a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements
- Manages QA personnel, including organizing and prioritizing daily tasks, performing training, and writing performance reviews
- Writes and/or implements changes to controlled documents (e.g., SOPs, specifications, methods, etc.) as needed to ensure defined quality objectives are met
- Implements and maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs)
- Reviews manufacturing, environmental monitoring and quality control data for in-process and finished products.
- Responsible for final release of manufactured products
- Works extensively with operating entities to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis, to enforce requirements and meet specifications
- May participate in the writing of annual product reviews and the development of training programs regarding all aspects of producing quality products
- Serves as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to manufactured products. May lead compliance audits as required
- Interfaces with contract manufacturers to address and resolve more complex product/process performance issues
- Works with Research and Development during new product start-ups, and establishes key checkpoints for new products and processes
May interface with regulatory agencies as requiredKnowledge, Experience and Skills:
- Ability to track and follow up on actions requiring completion
- Ability to lead and influence a cross-functional team as well as global site and functional area employees to a successful project outcome
- Objective and transparent with information
- Critical and strategic thinking skills and ability to provide pragmatic, risk-based, and phase appropriate guidance and decision-making even when quality and compliance requirements are not well-defined
- Awareness and application of global regulations and guidelines and industry best practices
- Ability to act as a mentor to junior staff
- Ability to provide clear perspective and rationale for thinking and function successfully in a dynamic environment
- An accountable team player who is detail and quality oriented with an in depth understanding of quality assurance principles, systems and procedures
- Excellent attitude with good verbal and interpersonal communication skills, excellent judgment, and multitasking skills who can work well in a dynamic environment
- 8+ years of experience in a GMP environment related field and a BS or BA.
- 6+ years of relevant experience and a MS
- Demonstrates in-depth knowledge of GMPs and/or GLPs
- Demonstrates in-depth knowledge of QA principles, concepts, industry practices, and standards
- Demonstrates excellent verbal, written, and interpersonal communication skills
- Demonstrates keen understanding of international quality systems regulations to adopt best in class systems/processes, and drive continuous improvement initiatives
- Demonstrates knowledge of Information Systems Technology, understanding of Computer System Validation (CSV) including current electronic records and signature requirements
- Knowledge of Six Sigma, Define-Measure-Analyze-Improve-Control (DMAIC) methodology, performance measures and quality improvement statistical is preferred
- Knowledge of Risk Management tools (e.g., Hazard Analysis and Critical Control Points (HACCP) and / or Failure Mode Effects Analysis (FMEA)) is preferred
- Certification by ASQ (Certified Quality Auditor, Certified Quality Engineer, and Certified Quality Manager) or other industry-recognized professional organizations is 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/GileadAbout 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.
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