Quality Assurance Manager

Your Role

The incumbent is responsible for the management of all aspects of Quality Assurance and provides daily support and supervision to the Quality Assurance Specialists.

ESSENTIAL DUTIES, RESPONSIBILITIES AND ACCOUNTABILITIES

• Project team member and primary customer contact for quality decisions and product oversight. Liaison for quality issues and execution of product release.
• Executes final release of product, ensuring batches meet all quality specifications and compliance requirements. Added responsibility for on-time release.
• Directs QA resources and workflow with Production and Shipping.
• Sets agenda scheduling and leads audits for external customers. Authors audit responses and ensures completion of associated CAPAs.
• Performs and trains QA staff on performing internal audits
• Provides QA leadership during technology transfers
• Integral to the management of regulatory agency inspections. Incumbent oversees flow of information, is responsible for responding to inquiries and developing strategy for risk mitigation.
• Prepares and tracks KPIs for upper management.
• Authors Standard Operating Procedures/Work Instructions and implements process changes.
• Decision-maker of quality requirements for change controls.
• Designs project scope and compliance requirements for Product and Equipment Validations, Qualifications and Assessments documents. Authors reports with scientifically sound conclusions.
• Acts as the primary liaison between QA and all other departments on day-to-day basis.
• Oversees the flow of logs and turnaround in the Department.
• Ensures QA requirements defined in Customer Quality Agreements are met.
• Acts as the primary contact for projects or issues that involve QA.
• Drives continuous improvement of GMP compliance and inspection readiness
• Participates in Inventory meetings.
• Prepares, reviews and approves Product Quality Reviews (PQRs) / Annual Product Reviews (APRs)
• Reviews and approves change controls and ensure compliance with global change control procedures
• Leads site readiness for regulatory inspections
• Reviews and approves Master Production Records as appropriate.
• Reviews and approves executed logs as appropriate.
• Reviews and approves deviations, investigation reports and CAPAs.
• Reviews and provides input to Drug Master Files (DMFs).
• Manages Customer complaints, inquiries and complete requests pertaining to QA.
• Participates in review and approval of all SOP’s that require QA signature.
• Ensures appropriate training and GMP awareness across site personnel
• Manages implementation and adherence to all applicable cGMP regulations.
• Oversees Quality Systems department
• Manages QA/QS budgets
• Ensures Environmental Monitoring (EM) for the site is on track
• Ensures that personal and departmental moral, ethical, legal, and behavioral conduct meets the Siegfried Code of Conduct.
• Adheres to all applicable SHE regulations.

Supervision

The incumbent directly supervises 5 to 10 QA/QS Specialists and is responsible for staffing, performance management, and training of the direct reports.

Education and Experience

• A BS degree in Chemistry, Chemical Engineering or equivalent technical field and/or 5-10 years’ experience in Quality Assurance for a pharmaceutical company
• Two to five years of leadership experience is required. In-depth knowledge of cGMP in a manufacturing environment is a must.

Other Requirements

• Must have excellent verbal and written communication skills.
• Must be able to work efficiently with people of all levels and cultures.
• Must have excellent coaching and interpersonal relationship skills.
• Must be conscientious and detail-oriented.
• Must be a team player.
• Must be a self-starter and initiator.
• Must have excellent project management skills.

Benefits

• Competitive performance-based bonus
• Employee Share Matching Plan
• 401(k) Match
• Medical, Dental, and Vision Offerings
• Life, Sickness and Accident insurance, and Long-term disability
• Increased Voluntary Life Insurance (employee and family) (optional)

Pay

The salary for this role is anticipated to be between $105,000 and $135,000