Quality Assurance Manager
Listed on 2026-07-02
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Quality Assurance - QA/QC
QA Specialist - Analyst/Manager, Regulatory Compliance Specialist, Quality Control - QC Analysts/Managers, Data Analyst
"Expect to grow", personally and professionally:
At Siegfried, we offer exciting challenges and ample opportunities to showcase your talents. As a trusted and respected partner to the pharmaceutical industry, we uphold the highest standards in safety, quality and sustainability, while fostering a culture that empowers you to thrive. Join a rapidly expanding global company, where diverse perspectives and experiences come together in a collaborative environment. Here, you'll find a workplace that values both collective success and your individual contributions—offering long-term opportunities to grow and make an impact.
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.
Your Profile: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 meets 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.
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…
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