Quality Assurance Manager

Location: Pennsville

## Quality Assurance Manager Apply locations:
Pennsville, NJtime type:
Full time posted on:
Posted Yesterday job requisition :
R26 568"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.
** 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.
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* 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.
** SUPERVISION:
** The incumbent directly supervises 5 to 10 QA/QS Specialists and is responsible for staffing, performance management, and training of the direct reports.
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* 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…