Sr. Manager, QA Commercial Product
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POST DATE 9/2/2016
END DATE 1/13/2017
Gilead Sciences, Inc
Foster City, CA
JOB DESCRIPTIONSPECIFIC RESPONSIBILITIES
With the commitment and drive you bring to the Pharmaceutical Development & Manufacturing (PDM) workplace, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. You will see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through on-going 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 PDM at Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.
We are seeking an energetic Quality Assurance professional, ideally with experience in commercial solid dose manufacturing operations with an in-depth knowledge of global regulatory and compliance requirements. The role is responsible for the administration of quality standards and practices within a multi-national organization, with direct quality management oversight of global third party contract manufacturers. This Quality professional will be a strategic leader in a cross-functional management team.
- Develops, establishes and maintains quality assurance programs and systems, policies, processes, procedures and controls ensuring that performance and quality of drug products conform to established standards and regulatory agency requirements.
- Providing expertise and guidance in interpreting governmental regulations, agency guidelines and internal policies to assure continued compliance.
- Working directly with operating entities (internal and CMOs) to ensure that commercial drug product operations remain in a compliant state, and product meets all required standards and specifications; specifically, managing commercial change control, lot disposition, quality investigations and CAPA resolution for solid dose products.
- Participate in external commercial quality audits; hosting internal audits by license partners, and representing Gilead during CMO site inspections by regulatory agencies.
- Draft, and/or review and approve Annual Quality Reviews and regulatory submissions.
- Create, review and/or review and approve standard operating procedures to ensure alignment with practices.
- Key strategic member of Quality Assurance management team in continually assessing quality systems, providing guidance and direction for improvement and implementation of efficiencies.
- Ability to work collaboratively with commercial and development product manufacturing teams, business partners and CMOs.
- Managing and mentoring a Quality Assurance staff of 2-4 Quality Assurance individuals.
ESSENTIAL DUTIES AND JOB FUNCTIONS
* Manages QA personnel, including organizing and prioritizing group tasks, performing training, and writing performance reviews. 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.
* 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
* 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 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.
* 10+ years of relevant experience in a GMP environment related field and a Bachelor s degree in science or related fields.
* 8+ 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/Gilead
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercialises 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.
As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. 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 email@example.com for assistance.
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