Associate Manager/Manager, Quality Assurance
Location: South San Francisco
Posted on: June 23, 2025
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Job Description:
Roles and responsibilities: The Associate Manager/Manager,
Quality Assurance - Quality Systems is responsible for supporting
the development, implementation, and maintenance of quality
systems, with a strong emphasis on electronic quality management
systems (eQMS) within a pharmaceutical/biopharmaceutical
environment. This role ensures compliance with relevant
regulations, standards, and company policies, and drives continuous
improvement in quality system processes. This role supports quality
systems related to GMP, GCP, and GLP, with a focus on 21 CFR Part
11 compliance and quality risk management. Electronic Quality
Management Systems (eQMS) Management: Administer and maintain the
company's eQMS, ensuring its effective use and compliance,
including compliance with 21 CFR Part 11. Manage user access,
system configurations, and data integrity within the eQMS, ensuring
adherence to 21 CFR Part 11 requirements for electronic records and
electronic signatures. Develop and deliver training programs for
employees on eQMS usage, quality system procedures, 21 CFR Part 11
compliance, and quality risk management principles. Provide support
and troubleshooting for eQMS users, including issues related to 21
CFR Part 11 compliance. Evaluate, recommend, and implement eQMS
upgrades and enhancements, ensuring continued 21 CFR Part 11
compliance and support for quality risk management. Quality System
Support: Support the development, implementation, and maintenance
of quality system procedures, including but not limited to:
Document Control Change Control (including change control for 21
CFR Part 11 compliant systems) Deviations/Non-Conformances
(including the application of quality risk management principles)
Corrective and Preventive Actions (CAPA) (including the application
of quality risk management principles) Audits (internal and
external) (including risk-based auditing) Training Validation
(including computer system validation, with a focus on 21 CFR Part
11 and risk-based validation) Quality Risk Management Ensure that
quality system documentation is accurate, complete, and compliant
with regulatory requirements, including 21 CFR Part 11, and
incorporates quality risk management principles. Participate in
internal and external audits, including preparation, execution, and
follow-up, with attention to 21 CFR Part 11 requirements and
risk-based approaches. Facilitate root cause analysis
investigations and the implementation of CAPAs, utilizing quality
risk management tools and techniques. Monitor quality system
performance metrics and identify areas for improvement, including
those related to 21 CFR Part 11 compliance and the effectiveness of
quality risk management processes. Compliance: Ensure compliance
with current Good Manufacturing Practices (cGMPs), Good Clinical
Practices (GCPs), Good Laboratory Practices (GLPs), FDA
regulations, ICH guidelines, 21 CFR Part 11, and other applicable
regulatory requirements, including those related to quality risk
management (e.g., ICH Q9). Stay current on changes in regulations
and industry trends related to quality systems, eQMS, 21 CFR Part
11, and quality risk management. Participate in regulatory
inspections and customer audits, with a focus on 21 CFR Part 11
compliance and quality risk management practices. Continuous
Improvement: Identify and implement opportunities to improve
quality system processes and enhance efficiency, including those
related to 21 CFR Part 11 compliance and the application of quality
risk management principles. Promote a culture of quality and
continuous improvement within the organization. Utilize lean
principles and other quality tools to drive process improvements,
incorporating quality risk management methodologies. Collaboration:
Collaborate with cross-functional teams, including Manufacturing,
Quality Control, Research and Development, Clinical Operations, and
Regulatory Affairs, to ensure quality system requirements,
including 21 CFR Part 11 and quality risk management requirements,
are met. Work with IT to ensure the eQMS and other computer systems
are properly supported, maintained, and compliant with 21 CFR Part
11, and that they support quality risk management processes.
Qualifications and Education Requirements: Bachelor's degree in a
scientific discipline (e.g., Biology, Chemistry, Pharmacy) or a
related field. Minimum of 3-5 years of experience in a Quality
Assurance or electronic system management role within the
pharmaceutical/biopharmaceutical industry. Strong knowledge of
cGMPs, GCPs, GLPs, FDA regulations, ICH guidelines, 21 CFR Part 11,
and other relevant regulatory requirements, including ICH Q9.
Experience in managing and administering electronic quality
management systems (eQMS) is required. Experience with specific
eQMS systems (e.g., Documentum, Veeva Vault, TrackWise, etc.) is
highly desirable. Excellent written and verbal communication
skills. Strong problem-solving and analytical skills, including
experience with quality risk management tools. Ability to work
independently and as part of a team. Detail-oriented with a strong
focus on accuracy and compliance. Proficiency in Microsoft Office
Suite (Word, Excel, PowerPoint). Preferred Qualifications:
Experience in validation of computerized systems, with a strong
emphasis on 21 CFR Part 11 compliance and risk-based validation.
Certification in quality management (e.g., ASQ Certified Quality
Auditor). Certification in electronic system administrator.
Experience with lean manufacturing or Six Sigma methodologies.
Preferred Skills: cGMP GCP GLP 21 CFR Part 11 FDA Regulations ICH
Guidelines Quality Systems eQMS Administration Document Control
Change Control CAPA Auditing Validation Compliance Problem-Solving
Communication Data Integrity Computerized System Validation Quality
Risk Management Note: This job description is intended to provide a
general overview of the responsibilities and qualifications for the
position. It is not intended to be an exhaustive list of all duties
and responsibilities. The company reserves the right to modify the
job description as needed. The exact title will be determined based
on the candidate's qualifications and experience. Salary range:
$110,000 to $160,000
Keywords: , Santa Rosa , Associate Manager/Manager, Quality Assurance, Science, Research & Development , South San Francisco, California
