Quality Assurance Manager

Siegfried•Pennsville, NJ

49d•$105,000 - $135,000•Onsite

About The Position

The incumbent is responsible for the management of all aspects of Quality Assurance and provides daily support and supervision to the Quality Assurance Specialists. Siegfried is a rapidly expanding global company, where diverse perspectives and experiences come together in a collaborative environment. Siegfried is one of the few organizations today that can carry out the development and manufacturing of APIs and finished dosage forms under one roof.

Requirements

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.
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.

Responsibilities

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