Job Description
Role 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.
Job Tags