Job Posting Title:Manager, Quality Systems Requisition Number: 4009
Country: US
State: California
Job Location: Foster City
Functional Area: QA/QC
Position Type: Regular
Shift: Days
Specific Responsibilities:
This position is responsible for management and/or oversight of quality systems such as annual quality reviews (AQRs), change control, and quality agreements to ensure compliance with applicable Pharmaceutical regulatory requirements.
•Requires an in-depth knowledge of current Good Manufacturing Practices (cGMPs).
•Requires strong organizational, technical, interpersonal, and Computer skills.
•Requires excellent verbal, written, and interpersonal communication skills.
•Participates in, or implements improvements to the commercial operations quality systems.
•Reviews and understands process information, analytical data, analysis of data trends and the impact of change on product and/or process.
•Revises SOPs for existing quality system for consistency and compliance with regulatory requirements and Gilead’s corporate policies and standards.
•Coordinates project timelines and manages multi-department working teams. Represents QA in project teams.
•Develops and delivers high quality reports according to SOP and management expectations.
•Ability to work on multiple projects in a fast-paced environment while maintaining quality output.
•May include QA personnel management.
This role typically requires a BA or BS and minimum 8 years of relevant progressive experience in the Pharmaceutical industry or a MS degree and minimum 6 years of relevant experience.
Experience should include:
•Strong understanding and application of GMP and quality assurance principles, concepts, industry practices and standards.
•Organization, management, and/or participation in cross-functional project activities.
•Strong technical writing abilities, including attention to detail and review skills.
•Moderate to advanced proficiency in Microsoft word and excel.
•Proficiency with Quality Management System (e.g. Trackwise, EQMS) and Laboratory Information Management Systems (LIMs) a plus.
•Strong prioritization and organization skills.
•Excellent teamwork, as well as verbal and written communication skills.
Essential Duties and Job Functions:
Manages QA Systems. Performs a wide variety of activities to ensure compliance with applicable regulatory requirements. Participates in developing Standard Operating Procedures to ensure quality. Maintains Quality Assurance programs, policies, processes, procedures and controls ensuring that performance and quality of products conform to established standards and agency guidelines. Provides expertise and guidance in interpreting governmental regulations, agency guidelines, and internal policies to assure compliance. May serve as a liaison between the company and the various governmental agencies. May interface with regulatory agencies as required. Writes and/or implements changes to controlled documents (e.g., SOPs, Specifications, Methods, etc.) as needed.
Knowledge, Experience and Skills:
Requires an in depth understanding and application of GMP Pharmaceutical manufacturing and quality assurance principles, concepts, practices, and standards. Must be able to work on problems ranging from semi-routine to moderately complex where analysis of situations or data requires in-depth evaluation of various factors. Exercises judgment within defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results, resolving problems, and/or making recommendations.
