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Miles
Km80.5

Associate Manager, Quality Assurance

Gilead Sciences

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Location: Oceanside, CA Posted Date: 4/17/2013 Position Type: Full time Job Code: 11351 Required Education: High school or equivalent Areas of Expertise Desired: Quality Assurance

Description

Supervises QA Documentation Specialist(s), including organizing and prioritizing daily tasks, performing training, and writing performance reviews. Responsible for coordinating all activities related to providing required documentation and implementing related documentation systems. Coordinates the review, creation and revision of batch records, procedures, methods, specifications and forms. Maintains paper and electronic filing system for validations, MRBs, batch records and other documentation related to the manufacture of bulk drug substances. Issues master production records as required. Schedules, administrates and participates in documentation change control meetings.
Manage the site’s training program to meet compliance goals, meet development needs, and support operational excellence initiatives.  Evaluate the effectiveness of trainings, implementing modifications, when necessary, and monitor training compliance for staff.
Provides day-to-day guidance and training to other QA personnel as required. Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (cGMPs). May support review of manufacturing, environmental monitoring and quality control data for in-process and finished products. Responsibilities may include the final release for all manufactured products. 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.
Responsibilities may also include oversight of site validation activities. Coordinates validation activities with Development, Manufacturing, Engineering, Quality, and other groups on projects. Manages the activities of assigned validation and contract personnel to ensure the quality of completed work. Provides technical assessment and validation approval for engineering and process changes. Reviews protocols, reports and data tables generated by peers and contract personnel. Represents the department on cross-functional project teams. As required, presents validations to regulatory authorities during routine internal and pre-approval inspections. Works independently to resolve complex validation issues with very limited direct supervision. Contributes to the development of new concepts, techniques, and standards. Develops solutions to a wide range of complex problems, which require the regular use of ingenuity and innovation.

Requirements

Must have a strong understanding of Quality Systems, training, auditing and validation. A thorough knowledge and understanding of large molecule manufacturing, quality assurance, and validation is preferred A record of leadership, change management, industry awareness, performance consulting, systems’ thinking, communication, needs analysis, program analysis, feedback and coaching skills is required.  Requires a thorough knowledge of the Code of Federal Regulations for current Good Manufacturing Practices (cGMP) and laboratory operations.
Works on problems routine in nature where analysis of situations or data requires evaluation of various factors. Exercises judgment with well defined and established practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. Strong verbal, written, and interpersonal communication skills are required. Working knowledge with a strong proficiency in Microsoft Office applications.

Specific Education and Experience Requirements:
Typically requires a BA or BS degree and minimum 7+ years of relevant progressive experience in the pharmaceutical industry, which includes 7 years managing timelines and resources or a MS or MBA and minimal 5+ years of relevant experience.  Experience should include participation in cross-functional project management activities.  Line management lead experience is desirable.  
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