Senior Manager, Quality Assurance CMO Oversight
Company: Gilead Sciences, Inc.
Location: San Mateo
Posted on: May 14, 2022
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Job Description:
Gilead Sciences, Inc. is a research-based biopharmaceutical
company founded in 1987. Together we deliver life-saving therapies
to patients in need. With the commitment and drive you bring to the
workplace every day, you will be part of a team that is changing
the world and helping millions of people live healthier, more
fulfilling lives. Our worldwide staff is a close community where
you can see the tangible results of your contributions, where every
individual matters, and everyone has a chance to enhance their
skills through ongoing 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
Gilead, you will further our mission to address unmet medical needs
and improve life by advancing the care of patients with
life-threatening diseases.
Role and Responsibilities:
Oversight of Gilead Contract Manufacturers:
--- Provides quality oversight for outsourced manufacturing and
packaging activities including master and executed batch records,
AQLs, investigations, operation start up, and packaging line
trials
--- Serves as Quality Functional Site Lead (QFSL) for assigned
CMO(s)
--- Leads weekly QA to QA meetings and represents QA in weekly
meetings with CMOs
--- Provides person in plant oversight for Commercial and Clinical
CMOs.
--- Drives, leads, and troubleshoots quality investigations at
contract manufacturers to ensure that all critical and major
quality issues are thoroughly investigated with appropriate
corrective actions
--- Ensures contract manufacturers are compliance ready for
regulatory inspections and monitor inspection progress during
inspections
--- Ensures quality review of contract manufacturer documents for
compliance with Gilead policies and procedures.
--- Implements and monitors Gilead's vendor management key
performance indicators at contract manufacturers
--- Ensures quality checks on on-going operations at contract
manufacturers for: API, Solid Dispersion, Drug Product
Manufacturing, Packaging & Labelling operations, Materials Control,
Proper contamination control, Good Documentation Practice,
Adherence to approved batch record instructions, Physical product
quality
--- Troubleshoots and provides quality decision on product quality
defects and AQL failures
--- Implements Gilead Good Distribution and Transportation
Practices at contract manufacturers and provide periodic monitoring
for compliance
--- Interacts with key stakeholders to ensure sufficient support
and oversight of CMOs in the areas of quality and compliance is
being provided.
--- Identifies, designs, and implements process and system
improvements
--- Drives continuous improvement both internally and at CMOs and
aligns with Gilead continuous improvement programs
--- Prepares and delivers Business Review Meeting content as
appropriate.
--- Supports quality agreement implementation and updates
--- Provides audit support of Gilead contract manufacturers as
required
--- Reports on performance at CMOs for overall site metrics, key
issues to be presented at the Business Review Meeting
--- Manages competing priorities, allocates and assigns department
resources to meet targets and timelines
Essential Duties and Job Functions:
--- 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
--- Interacts with contract manufacturers to address and resolves
more complex product/process performance 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:
--- Strong experience with leading and managing quality
investigations
--- Strong strategic thinking and planning skills is a plus
--- Strong knowledge of cGMP (US, Canada, and Europe) requirements
as applicable to both drug products (solid oral dosage forms,
parenteral and medical device products). Experience in
investigational devices is desirable
--- Experience in managing contract manufacturing organizations and
driving process improvements
--- Experience in writing and reviewing Quality Agreements with
contract manufacturers
--- Auditing experience on contract manufacturing organizations
--- Certified Quality Auditor or other accreditation would be a
plus
---Strong leadership, critical thinking and negotiation skills
--- Must have excellent verbal, written and interpersonal
communication skills
--- Able to travel for 10 - 15% of time is required
--- 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 strategic/critical thinking and problem-solving
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
Basic Qualifications:
About Gilead:
Gilead Sciences, Inc. is a research-based biopharmaceutical company
that discovers, develops and commercializes 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.
For jobs in the United States:
As an equal opportunity employer, Gilead Sciences Inc. is committed
to a diverse workforce. Employment decisions regarding recruitment
and selection will be made without discrimination based on race,
color, religion, national origin, gender, age, sexual orientation,
physical or mental disability, genetic information or
characteristic, gender identity and expression, veteran status, or
other non-job related characteristics or other prohibited grounds
specified in applicable federal, state and local laws. 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 for assistance.
Following extensive monitoring, research, consideration of business
implications and advice from internal and external experts, Gilead
has made the decision to require all U.S. employees and contractors
to receive the COVID-19 vaccines as a condition of employment.
"Full vaccination" is defined as two weeks after both doses of a
two-dose vaccine or two weeks since a single-dose vaccine has been
administered. Anyone unable to be vaccinated, either because of a
sincerely held religious belief or a medical condition or
disability that prevents them from being vaccinated, can request a
reasonable accommodation.---
For more information about equal employment opportunity
protections, please view the 'EEO is the Law' poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
PAY TRANSPARENCY NONDISCRIMINATION PROVISION
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Keywords: Gilead Sciences, Inc., San Mateo , Senior Manager, Quality Assurance CMO Oversight, Executive , San Mateo, California
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