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:
Oversight of Gilead Contract Manufacturers:
• Provides quality oversight for outsourced manufacturing and packaging activities including master and executed batch records, AQLs, investigations, operation start up, and packaging line trials
• Serves as Quality Functional Site Lead (QFSL) for assigned CMO(s)
• Leads weekly QA to QA meetings and represents QA in weekly meetings with CMOs
• Provides person in plant oversight for Commercial and Clinical CMOs.
• Drives, leads, and troubleshoots quality investigations at contract manufacturers to ensure that all critical and major quality issues are thoroughly investigated with appropriate corrective actions
• Ensures contract manufacturers are compliance ready for regulatory inspections and monitor inspection progress during inspections
• Ensures quality review of contract manufacturer documents for compliance with Gilead policies and procedures.
• Implements and monitors Gilead's vendor management key performance indicators at contract manufacturers
• Ensures quality checks on on-going operations at contract manufacturers for: API, Solid Dispersion, Drug Product Manufacturing, Packaging & Labelling operations, Materials Control, Proper contamination control, Good Documentation Practice, Adherence to approved batch record instructions, Physical product quality
• Troubleshoots and provides quality decision on product quality defects and AQL failures
• Implements Gilead Good Distribution and Transportation Practices at contract manufacturers and provide periodic monitoring for compliance
• Interacts with key stakeholders to ensure sufficient support and oversight of CMOs in the areas of quality and compliance is being provided.
• Identifies, designs, and implements process and system improvements
• Drives continuous improvement both internally and at CMOs and aligns with Gilead continuous improvement programs
• Prepares and delivers Business Review Meeting content as appropriate.
• Supports quality agreement implementation and updates
• Provides audit support of Gilead contract manufacturers as required
• Reports on performance at CMOs for overall site metrics, key issues to be presented at the Business Review Meeting
• Manages competing priorities, allocates and assigns department resources to meet targets and timelinesEssential Duties and Job Functions:
• Performs a wide variety of activities to ensure compliance with applicable regulatory requirements
• Participates in developing Standard Operating Procedures to ensure quality across internal and CMO operations
• Maintains Quality Assurance programs, policies, processes, procedures and controls ensuring that performance and quality of products conform to established standards and agency guidelines
• Works directly with operating entities to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications
• Ensures that inspections are conducted of raw materials, ingredients, and product according to specifications
• Ensures compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs)
• Leads compliance audits as required. Interfaces with contract manufacturers to address documentation and compliance issues
• Interacts with contract manufacturers to address and resolves more complex product/process performance issues
• May interface with regulatory agencies as required
• Writes and/or implements changes to controlled documents (e.g., SOPs, Specifications, Methods, etc.) as needed
• Some positions at this level may specialize in transferring and driving quality initiatives across CMO organizations – this would include areas like CMP review, selection, CMO technology transfer, CMO process improvement, CMO technical management, etc.Knowledge, Experience and Skills:•
Strong experience with leading and managing quality investigations
• Strong strategic thinking and planning skills is a plus
• Strong knowledge of cGMP (US, Canada, and Europe) requirements as applicable to both drug products (solid oral dosage forms, parenteral and medical device products). Experience in investigational devices is desirable
• Experience in managing contract manufacturing organizations and driving process improvements
• Experience in writing and reviewing Quality Agreements with contract manufacturers
• Auditing experience on contract manufacturing organizations
• Certified Quality Auditor or other accreditation would be a plus
•Strong leadership, critical thinking and negotiation skills
• Must have excellent verbal, written and interpersonal communication skills
• Able to travel for 10 – 15% of time is required
• Demonstrates in-depth knowledge of Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs)
• Demonstrates in-depth knowledge of QA principles, concepts, industry practices, and standards
• Demonstrates keen understanding of Computer Systems Validation and ICH Guidelines
• Demonstrates excellent verbal, written and interpersonal communication skills
• Demonstrates strategic/critical thinking and problem-solving skills
• 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 organizationsBasic Qualifications:
- 8+ years of experience in a GMP environment related field and a BS or BA.
- 6+ years of relevant experience and a MS.
- 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/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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