Job Description

Oversees operational aspects of the Quality Assurance department related to the manufacturing of products in strict accordance with all SOPs, cGMPs, company policies and procedures, and FDA requirements governing the manufacturing of pharmaceutical products.

Essential Functions:

• Oversees, manages, coordinates and prioritizes the daily activities of the Quality Assurance department and assign staff. Carries out all managerial responsibilities in accordance with the company's policies, procedures, state, federal and local laws. Ensures and enforces departmental compliance of all related facility SOPs and cGMPs. Coordinates with Operations, Engineering, QC, and R&D to ensure compliance with and understanding of cGMPs, company policies, practices, and safety procedures. Ensures project deadlines and performance standards are established and met. Participate in new projects development and implementation to launch products in a timely manner according to regulatory requirements.

• Leads and manages Quality Assurance department to include incoming raw material/packaging components, in processes, packaging/labeling and audits. Oversees performance of equipment cleaning for both manufacturing and packaging equipment. Oversees and manages QA activities for multiple sites (Warehouse, Manufacturing/Packaging facilities). Investigates problems and causes of deviations and propose corrective and preventive actions. Writes and reviews SOPs, protocols and change controls. Ensures cGMP and FDA compliance by all employees to best practices, standards and quality. Oversees facility environment, monitoring and purified water release. Monitors quality/customer complaints, returned goods and PBR reviewing. Manages Quality systems that support compliant plant operations. Reviews all manufacturing deviations and approves as required. Reviews and/or approves all facility SOPs as required. Reviews APR's for all products that are being manufactured. Work cross functionally with Contract Manufacturing Organizations (CMOs) and to review and approve change controls and process related investigations. Manages all cGMP documentation and record archiving as required. Oversees inspection/inventory of all printed material.

• Participates in the recruitment process of interviewing and hiring. Conducts performance evaluations of direct reports and assists direct report supervisors with the performance evaluation process. Provides support, direction, and coaching to subordinate employees in the area of hiring, training, disciplinary action, problem resolution, planning and work assignment delegation.

• Leads and manages Internal and Cross functional systems audits (Self Audits). Prepare audit observations for self-audits and ensures that on-time completion of final audit reports for both Internal and Self Audits. Perform risk assessment for compliance and recommended corrective measures and preventive measures to mitigate potential compliance risks.

• Manages, reviews, and finalizes with department supervisors or designees the completion of inspections and audits to ensure compliance with cGMPs, SOPs, company practices, procedures and government regulations.

• Prepares and manages the department budget (as required); evaluates new equipment, capital expenditures and submits purchase recommendations.

Additional Responsibilities:

• Selects, trains, supervises and evaluates the performance of QA Supervisors and staff.

• Reviews, monitors leave/absenteeism of direct subordinates.

• Reviews work performance of all QA Inspectors/Reviewers.

• Oversees cross training of all QA personnel.

• Assists QA Director on all new projects and hiring.

• Participate in other compliance related projects as assigned by QA Director or above level.

Education:

• Bachelors Degree (BA/BS) Chemistry, Biology, Pharmacy, Engineering, or other related technical or business administration field - Required

Experience:

• 8 years or more in in FDA-regulated industry. Experience on different dosage forms.

• 8 years or more in 8 years of management of people, projects, functional area or a combination is required.

Specialized Knowledge:

• Thorough understanding and familiarity with GMP regulations including 21 CFR 210 and 211, 21CFR820, ICH Q9 (Quality Risk Management) and Q10 (Pharmaceutical Quality System) guidelines, FDA guidance Documents, familiarity with GLP regulations.

Licenses: