Reports to: Vice President, Quality
PURPOSE, OBJECTIVES, FUNCTIONS:
The Quality Assurance Director is responsible for Quality oversight of contract manufacturing (CMO) and testing activities. Acts as primary quality contact/liaison with CMO and partner quality organizations. Manages cross-functional teams for internal and external investigations. Serves as product quality representative on cross functional project teams. Participates in quality initiatives such as regulatory inspection preparations (internal and external).
PRINCIPAL DUTIES AND RESPONSIBILITIES:
Essential Functions:
- Oversight of the quality activities associated with manufacturing, testing and disposition of commercial products
- Review/approval of CMO batch records and associated GMP documentation (i.e. laboratory/manufacturing investigations, deviations, complaint investigations and validation documentation)
- Oversight of Stability program initiatives and support of Regulatory filings
- Monitor, review and approve analytical/stability data, protocols and reports
- Interface with cross functional groups to initiate/maintain change control and corrective action/preventative action (CAPA) associated with CMO operations
- Ensure internal and CMO KPI reviews are conducted and appropriate signal detection and mitigation processes are in place
- Facilitate the internal Event Review Board (ERB) process
- Facilitate weekly cross-functional review of Change Controls and Issues in Master Control to assure proper attention and timely resolution/completion
- Lead cross-functional teams made up of mfg, quality, and development SMEs for both internal and external resources to bring investigations to closure
- Generation and maintenance of Quality Agreements
- Ensure quality aspects of technology transfers for manufacturing sites and laboratories are properly executed
- Support regulatory inspections and lead inspection preparation teams as needed
- Preparation of Annual Product Reviews with interpretation and appropriate recommendations/conclusions provided
- Support the preparation of the quarterly Quality Management Review meetings
- Support activities during regulatory agency inspections, notified third party audits, and customer audits
- Support internal audit conduct and reporting
- Management of support staff including professional development and performance evaluation
Additional Responsibilities:
- Identify/predict resource needs
- Budget inputs and management of discretionary spending
AUTHORITIES:
- Identify and report possible preventative and corrective actions
- Identify opportunities for quality improvements and lead them
- Assess and communicate relative risks to diverse cross functional team
EMPLOYMENT REQUIREMENTS:
- Bachelor’s degree in Life Sciences; Master’s degree preferred. A combination of relevant education and applicable job experience may be considered.
- 8-12 years of progressively responsible QA related experience within the aseptic/ sterile pharmaceutical and/or device industry including direct experience with manufacturing and/or CMOs and testing laboratories; a minimum of 6 years in a leadership role.
- Six Sigma experience and/or certification a plus.
POSITION QUALIFICATIONS:
- Demonstrated knowledge and experience in the interpretation and application of 21 CFR 4, 11, 211, 820, ISO13485 and 14971, ICH, QSIT requirements for aseptically processed and terminally sterilized products
- Experience with review and approval of CMO batch records and associated GMP documentation
- Experience using electronic quality systems for documentation and processes, (i.e. MasterControl, TrackWise, etc.)
- Ability to prioritize work and handle multiple assignments, while maintaining a high level of quality
- Ability to travel both domestically and internationally as needed (25%)
- Excellent influencing, communication and interpersonal skills, as well as the ability to influence and interact at multiple levels of the organization (both internally and externally), manage multiple priorities, and deliver results
- Participation in cross-functional teams to achieve quality and process improvements is required
- Demonstrated analytical abilities and proficient planning and negotiation skills
Contact me at brian.safchik@apisearchgroup.com for more info
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