Title:  Manager, Quality Assurance

JOB PURPOSE 

Responsible for the staffing, organization, operation, budget, and maintenance of all activities related to QA monitoring of production activities, assuring that products are manufactured in compliance with cGMP guidelines, USP and FDA, EU requirements. In addition, directs batch record review, control and release, investigation process (CAPA) assuring that any discrepancies are investigated thoroughly and in a timely manner. Responsible for approving all the Change Controls (initial and final reviews), getting all the batch record documents approved after revision, providing QA related metrics to different levels of the organization. Work closely with compliance group at times of external audits (FDA or vendors). Responsible for directing and managing people and systems that assure product quality. Ensure that non-compliant situations are thoroughly investigated.

 KEY ACCOUNTABILITIES 

• Regular and predictable onsite attendance and punctuality.
• Directs the batch record review process. Makes final accept/reject disposition on product lots.  Assures batch is manufactured in compliance with NDA/ANDA/EU, cGMP and Validation parameters. Ensures that records are reviewed and released in a timely manner.
• Coordinates communication for status of lots and status of and resolves issues related to accept/reject disposition of batches.
• Places lots on HOLD if Quality issues are detected and notifies senior management.
• Coordinates destruction of rejected finished goods and assures destruction occurs in a timely manner.
• Expedites and prioritizes product releases by coordinating the Review, testing, and releases with site management to meet customer service requirements.
• Conducts routine investigation and departmental meetings to facilitate the performance of release function. 
• Manages personnel for in-process filling and inspection/packaging monitoring.
• Provide QA oversight of Operation for the entire Manufacturing process, supporting Clean room technicians and production technicians as needed to identify and address product quality compliance issues as they arise.
• Provide training and assistance to all Clean room and operation personnel for NCR, CAPA and Change Control.
• Provides QA review and approval of manufacturing investigations assuring timely review, follow-up, tracking and trending of MIRs. Perform Root Cause analysis and assure corrective action (CAPA) implementation associated with manufacturing investigations. Provide guidance to the investigation scientists on reporting and metrics required for different levels within organization.
• Performs QA review and approval of LIR’s (Laboratory Investigation Reports). 
• Reviews and approves SOPs, Job-Aids, Specifications, FMEA documents, Change Controls and Validation documents (Protocols, GTR’s, Commissioning Documents, FAT’s), engineering documents.
• Establish a qualification and Requalification program for Clean Room Certification and Recertification, for ISO 5 and 7 environments.
• Develop and implement Quality Systems Improvements through participation in cross functional teams. Performs and/or assures cGMP and technical training for and certification of staff.
• Assists the QA management in developing on department budget.
• Attends interdepartmental meetings representing Quality Assurance and makes sound quality decisions.
• Manages attendance records for all direct reports.

 COMMUNICATIONS & WORKING RELATIONSHIPS

Internal

• Routinely coordinates with supply chain, clean room manager and packaging manager to ensure release priorities are met and appropriate coverage for the operations

QUALIFICATIONS, EXPERIENCE, & SKILLS 

QUALIFICATIONS

• Minimum:    Bachelor’s degree in Pharmacy, Biology, Chemistry or a related field
• Preferred:   Additional college courses in Microbiology, cGMPs, Statistics or Quality Management are beneficial

EXPERIENCE

• Minimum:    Five years of professional experience in Compounding Facilities/Pharmaceutical Industry

SKILLS

• Must have history of strong documentation skills and attention to detail
• Familiarity with cGMPs and CFR for US and EU
• Excellent organizational skills and ability to multi-task and perform work in a timely manner
• Demonstrates ability to lead a department, projects and meetings effectively
• Ability to work in a team environment with good communication skills and ability to communicate effectively with peers, and senior management
• General computer skills and ability to prepare presentations and address large groups
• Demonstrated attention to details and accuracy

• The incumbent must possess the strong knowledge of quality assurance systems. Dealing with FDA, third party during inspection is a must
• Mentoring abilities as well as effective communication, (written and oral) are required