Sr. Manager, Quality Assurance and Compliance
San Diego, CA
Areas of Expertise Desired:
Santarus, a speciality biopharmaceutical company based in San Diego, has an exciting opportunity for a Manager, Quality Assurance and Compliance to join our team.
This position is responsible for managing GMP batch record, quality investigation review and lot release activities for products manufactured from multiple Contract Manufacturing Organizations (CMOs) for clinical and commercial Santarus products. In addition, perform internal and external audits and support the audit program activities. , This position will play a major role in implementing and managing an internal and external exception program providing critical input for deviations, variances, Out of Trend (OOT) and Out of Specification (OOS) investigations including CAPAs. The position assists the Complaints program, coordinating intake of Complaints and investigations. In relation to these activities this position will play a key role in the Quality Oversight activities at CMOs that includes providing performance and audit metrics for periodic CMO and product reviews. This position will also play a key role in supporting critical manufacturing activities (e.g., qualification, validation, packaging, etc.) and oversee these activities on site at the CMO when applicable. The position will also contribute to the GXP Change Control Program at Santarus and in cooperation with CMO change control systems.
DUTIES & RESPONSIBILITIES:
Essential duties and responsibilities include the following. Other duties may be assigned.
1. Manage Lot Release Activities
• Manage the review and approval of documentation for lot release of commercial product and clinical trial materials (CTMs)
• Lead the resolution of “exceptions” and variance /deviations for lot release documentation
• Review investigations for closure and appropriate Corrective and Preventive Action Plan (CAPA)
• Provide critical input in the final disposition of production materials in support of QA teams
• Approve final disposition of product
• Provide critical information needed to maintain the QA lot release metrics program
2. Audit Program
• Contribute to the development and maintenance of Santarus Internal & External Audit Schedule
• Manage development of audit agenda/plans and schedule with applicable departments and/or Suppliers
• Perform GMP audits as primary auditor or lead auditor of an audit team
• Review or write audit reports and assure the evaluation and monitoring of audit observation responses
• Assure the effective monitoring and tracking of audit corrective actions through close-out
• Contribute to maintenance of Master Supplier List and Approved/Active Supplier List
• Report internal compliance status to Santarus RA/QA management
3. Quality Oversight and Reporting activities at CMOs
• Manage deviation/variance reporting compliance (CAPA)
• Manage CMO Change Control requests submitted to for review, approval, and/or notification of closure
• Assist in the review and approval of process validation protocols and reports
• Lead internal / external discussion/action teams to address compliance issues
• Attend and participate in Santarus / CMO product team meetings and teleconferences
• Assist with the Annual Product Review (APR) process from CMOs by assuring that APRs are received in a timely manner; and assuring that the information and data that they contain is complete and accurate for inclusion in the regulatory Annual Reports
• Assist with preparation of periodic CMO Management Reviews by compiling metrics and preparing slides
4. Product Complaint system
• Assist with the administration, maintenance and development of the product complaint system
• Assure complaint investigation, CAPA and close out
5. Participate in the Santarus Change Control program
• Review and approval of Master Production Records and material specifications
• Lead the monitoring of change control activities at CMOs
6. Assist with the review and approval process for commercial labeling materials
Perform all duties in keeping with the Company’s core values, policies and all applicable regulations.
EDUCATION / EXPERIENCE:
1. BA/BS with science major, or an equivalent combination of education and experience.
2. Minimum of 5-8 years experience in the pharmaceutical or biotechnology industry with at least 3 years in QA Lot Release programs.
3. Experience in conducting biopharmaceutical manufacturing, packaging, laboratory, warehousing quality systems audits.
4. Experience with pharmaceutical industry CAPA systems and change control programs.
5. Extensive knowledge of cGMPs and quality systems.
6. Excellent oral and written communication skills.
7. Competency in Microsoft Project, Word, Excel and PowerPoint.
8. Experience in pharmaceutical or biotechnology manufacturing arena.
1. Some IT background.
2. Experience serving on multidisciplinary teams.
3. Certified Quality Auditor credentials.
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