What are the responsibilities and job description for the Quality Systems Manager position at Piramal Pharma Solutions?
Business: Pharma Solutions
Department: Quality Assurance
Location: Lexington
Job Overview
The Quality Systems Manager is responsible for the documented assurance that all pharmaceutical manufacturing operations are controlled and managed in compliance with cGMPs, various industry regulations, and internal PPS standards.
Reporting Structure
Directly reports to Director of Quality
Key Responsibilities
- Coordinate the implementation and maintenance of regulatory documents applicable to PPS, including but not limited to: Quality Manual, Site Master File, Drug Master File(s), etc.
- Coordinate and review all Quality (Technical) Agreements prior to senior management approval
- Manage Document Systems (DS) documentation and data management and archival functions
- Support customer audits and regulatory inspections and assist in responding to observations as required
- Provide oversight on Quality Management Systems activities including end user administration duties for electronic management systems
- Review and approve change management documentation
- Ensure that finished product complaint investigations are conducted, resolved, and closed in a timely manner
- Evaluate and approve change controls as part of the overall change management program
- Ensure Quality systems are compliant with corporate and site procedures as well as industry standards such as but not limited to Annual Product reviews, Complaints, Investigations and Root Cause Analysis, Corrective and Preventive Actions, and Training
- Other duties as required by organizational needs
Education Requirements
- Bachelor’s Degree in the physical or biological sciences or engineering
Experience
- Minimum (7) years progressive experience in a cGMP regulated industry is required, sterile manufacturing and/or contract manufacturing strongly preferred
- Experienced in oversight of Quality Management Systems, Document Systems and Training
- Previous experience managing direct reports or leading teams
Competencies
- Thorough working knowledge of cGMPs, including: FDA, JP, and EU regulations
- Demonstrated proficiency and understanding of cGMP quality systems, including: CA/PA, root-cause analysis, risk assessment and investigation tools and techniques
- Tactful communication skills, both written and verbal
- Proven track record of forging positive working relationships with other leadership team members and use influence to achieve site goals
- Must be knowledgeable in ICH, and FDA guidelines
- Thorough knowledge of the regulatory approval process for US, EU, and JP
- Seasoned communicator, ability to interface effectively with all levels of the organization and clients
- High level of proficiency operating all Microsoft Office applications
- Comfortable with public speaking and conducting training for large groups
