Manager, Quality Assurance - Clinical QA Support
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POST DATE 8/18/2016
END DATE 11/17/2016
Gilead Sciences, Inc
Foster City, CA
JOB DESCRIPTIONSPECIFIC RESPONSIBILITIES
With the commitment and drive you bring to the 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.
Specific Responsibilities :
* Lead a team of QA specialists and contractors in the areas of continuous improvement, inspection support, training, EET/CAPA tracking, metric reporting, and system design, implementation, and optimization
* Lead and provide strategic oversight for Clinical QA improvement core team and voice of the customer initiatives and monitor employee and stakeholder needs to drive continuous improvement efforts
* Lead efforts to update and streamline Clinical QA processes and SOPs by reviewing existing workflows and assist in identifying areas for improvement, design flowcharts for identified areas and write/revise SOPs to drive improvement
* Lead RACI (Responsible, Accountable, Consulted, and Informed) charting analysis where needed
* Manage and provide strategic oversight for the design, implementation, integration, and continuous improvement of key software solutions (TrackWise, LIMS, EBS, and Gilead s batch disposition, business analytics, and CXO interface tools)
* Design, implement, and manage Clinical QA Quality Plan
* Design and maintain resource forecasting models for Clinical QA
* Manage internal and CXO investigations ensuring quality issues are thoroughly investigated with appropriate root cause analysis and corrective and preventive actions identified
* Manage internal audits for Clinical QA ensuring appropriate system improvements are identified and implemented and audit observations are responded to and closed in a timely manner
* Coordinate inspection and audit support for Clinical QA inspections and audits
* Review and may approve change control requests, investigations, and proposed corrective and preventative actions to ensure compliance with Gilead procedures, cGMP and all other applicable regulations
* Manage Clinical QA input and Metrics output for Gilead s Business Analytics System
* Manage Clinical QA training requirements and curricula, OJT qualification programs, and New Employee Onboarding programs to drive improved employee qualification and training compliance
* Maintain systems for organizing, tracking, trending and reporting Deviation, CAPA, batch disposition and review metrics
* Prepare presentations for management review and routinely monitor performance to drive improvements
* Other responsibilities as assigned
Specific Required Skills:
* In depth knowledge of Quality Systems and international cGMP standards
* In depth knowledge and experience with Operational Excellence Principles
* 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
* Strong leadership and negotiation skills
* An accountable leader who is detail and quality oriented with a solid understanding of quality principles, methods, and procedures
* Critical and strategic thinking skills
* Working knowledge of GMPs and regulatory requirements (US, Canada, and EU)
* Experience generating key metrics
* Technical writing skills
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 required.
KNOWLEDGE, EXPERIENCE AND SKILLS
* 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.
* 8+ years of experience in a GMP environment related field and a BS or BA.
* 6+ years of relevant experience and a MS.
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.
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 firstname.lastname@example.org for assistance.
For more information about equal employment opportunity protections, view the EEO is the Law poster at :