Manager, Quality Operations

Ferring Pharmaceuticals A/S

Ph.d. & forskning
Udlandet (øvrige)

Manager, Quality Operations


Job Title:

Manager, Quality OperationsJob Description:

Ferring Pharmaceuticals is a globally recognized, research-driven, biopharmaceutical company with more than 65 years of history. Headquartered in Switzerland, Ferring is privately owned with approximately 6,500 employees in nearly 60 countries. In the United States, Ferring identifies, develops and markets innovative products in the fields of reproductive medicine (infertility), urology, gastroenterology, endocrinology, maternal health (obstetrics/gynecology), orthopedics and Oncology. Ferring’s US operations employ approximately 900 people.

People Come First At Ferring. The Ferring Philosophy places people at the heart of what we do. This guides our relations with patients, physicians, employees, and other stakeholders. We invite you to share our passion for people and the power of science.

Summary:

Manage and perform activities related to QA oversight of manufacturing, packaging/labeling, inspection, QC laboratory, and plant maintenance / engineering. Assure that all products manufactured at the site and contract manufacturing organizations meet all established specifications, cGMPs, and all associated regulatory requirements. Responsible for the review and approval of executed batch records: media fills, compounding/filling/capping/terminal sterilization, visual inspection, labeling and packaging. Release of final packaged product for shipping to offsite warehouse. Meet department metric for schedule adherence.

Drive Ferring US and corporate quality compliance oversight and promote quality improvement. Maintain acceptable GMP regulatory compliance and quality performance. Prevent and mitigate quality risks which can jeopardize Ferring's interests (patient safety, supply continuity, reputation).

Responsibilities:

Oversee team of QA employees responsible for the oversight of manufacturing, packaging/labeling, inspection, QC laboratory, and plant maintenance/engineering

Examples include, but not limited to:

  • Provides oversight of manufacturing unit operations (e.g. compounding, filling, packaging and inspection); review/approval maintenance preventive maintenance changes; review/approval of critical equipment, systems, and utility issues and investigations; and establishes metrics to track and trend operations, as necessary.
  • Initiates and/or performs deviation investigations for quality/compliance related matters and partners with Product Supply leadership to bring issues to timely closure
  • Support technical transfer of new products. Create and update specifications needed for material. Approve and build of specifications in LIMS .
  • Review/approval equipment qualification documentation
  • Handle all product quality complaints stemming from FPG production/packaging areas within the allowed timeline. Investigate the complaint and upload to QA-Track for closure.
  • Write, review and approve quality SOPs to ensure cGMP compliance as required. Perform the periodic review for any SOPs associated with the job function.
  • Review and approve cross functional SOPs on behalf of Quality.
  • Investigate damaged incoming shipments to the warehouse. Photograph and perform visual inspection to be entered in the deviation to determine the disposition of the damaged shipment for use.
  • Perform weekly monitoring of materials in the FPG warehouse to ensure that expired materials are rejected for use and removed from the GMP areas.
  • Participate in all regulatory inspections as subject matter expert for areas of major responsibility and support others areas/functions where necessary.
  • Prepare and present to the Quality Review Board for areas of major responsibility.
  • Manage the Annual Product Review process, including scheduling, collection of data, report preparation and recommendations for product improvements

Requirements:

  • Minimum of a Bachelor of Science degree in Life Sciences or Pharmacy from an accredited college/university.
  • At least 10 years of total business experience in the pharmaceutical or biotechnology industry with at least 7 years of progressive experience in QA related functions with at least 5 years supervisory experience is required.
  • Direct, hands-on experience working in at least two of the following GMP cross functional areas is highly preferred: Quality Control, Supplier Quality, GMP Manufacturing or Technical Services is highly preferred.
  • Aseptic/sterile pharmaceutical manufacturing / facility experience is highly preferred.
  • Experience with Trackwise or similar system is required

We are proud to be an Affirmative Action/EEO Employer. EOE Minorities/Females/Protected Veterans/Disabled

We maintain a drug-free workplace and perform pre-employment substance abuse testing.

If you need assistance during the application process due to a disability, please email careers@ferring.com.

Location:

Parsippany


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https://jobbank.dk/job/1451493/