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Director Quality Systems - Global QA
Foster City, CA
Req# 1286
Gilead Sciences is a biopharmaceutical company that discovers, develops
and commercializes innovative therapeutics in areas of unmet medical
need. Our mission is to advance the care of patients suffering from
life-threatening diseases worldwide. Headquartered in Foster City, CA,
Gilead has operations in the United States, Europe and Australia.
Specific Responsibilities: Lead in the identification and implementation
of quality systems across GMP regulated areas of the company as well as
addressing commercial manufacturing challenges as required. Essential
skill sets include ongoing vigilance into emerging regulatory agency
mandates and industry best practice to dynamically evaluate current
processes and necessity for potential improvements. Responsibilities
will include working directly with and/or influencing operating entities
to ensure that the quality system program is robustly operational across
the organization. Interprets all issued dashboards, annual product
reviews and training programs to proactively assess and communicate
areas which need additional controls and/or enhancements. Works with
internal customers to establish key checkpoints for new products and
processes. Interfaces with contract manufacturers to establish and
nurture relationships associated with quality oversight while promoting
inter-company communication. Manages QA personnel, to include organizing
and prioritizing group tasks, performing training and writing
performance reviews. Performs a wide variety of activities to ensure the
development of quality systems across all functional areas of
responsibility - while maintaining compliance with applicable regulatory
requirements. May be required to assist in compliance assessments of
both established and potential partnerships - as required. Should be
comfortable interacting with regulatory agencies as needed and possess
the ability to represent the company (and industry) in public forums.
Develops staffing aligned with business needs while monitoring budget
and overall expenditures.
Essential Duties and Job Functions: ï Manages QA personnel, including
organizing and prioritizing daily 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.
Implements and maintains programs and processes to ensure high quality
products and compliance with current Good Manufacturing Practices
(cGMPs) and Good Laboratory Practices (GLPs).
Reviews 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.
May participate in the writing of annual product reviews and the
development of training programs regarding all aspects of producing
quality products.
May conduct or serve as a lead/coordinator of investigations and
corrective and preventive action (CAPA) recommendations related to
manufactured products.
Works with Research and Development during new product start-ups, and
establishes key checkpoints for new products and processes.
May lead 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.
Knowledge, Experience and Skills: Must have an in depth understanding
and application of principles, concepts, practices, and standards.
Must be able to work on problems ranging from semi routine to
moderately complex in scope where analysis of situations or data
requires in-depth evaluation of various factors, considerable judgment
is required in resolving problems and making routine recommendations.
Exercises judgment within defined practices and policies in selecting
methods, techniques and evaluation criteria for obtaining results.
Excellent verbal, written, and interpersonal communication skills are
required.
Typically requires a BS degree, 15 to 20 years of relevant experience in
the pharmaceutical industry with a minimum of 5 years of direct
Quality Systems background.
Reference Req# 1286 and apply online today at:
https://gilead.apply2jobs.com/index.cfm?fuseaction=mExternal.showJob&RID=1286&CurrentPage=1
We are an Equal Opportunity Employer
Posted 10/1/2008
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