- 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.
The Director, Quality Control (QC) is responsible for providing strategic direction and management of QC group (Analytical and Microbiology) activities for Ferring Production Inc (FPG). QC testing at contract testing laboratories for drug substance, drug product and for Stability Programs for the commercial and developmental portfolio.
This individual will work closely with other areas such as Pharmaceutical Development, Technical Operations, Quality Assurance and CMC Regulatory Affairs to manage the method transfers, methods validation, and data oversight and ensure timelines coincide with process development and production schedules. This includes vendor oversight, data review, external auditing, exceptions management (Deviations, CAPAs, OOS/OOT), and change control as it relates to GMP quality testing.
The incumbent will oversee designation of critical quality attributes, trending of method performance as well as in process, release and stability data, and setting of specifications. This position directs method transfers and method validation and is knowledgeable regarding worldwide regulations / guidance and global quality systems for laboratory controls.
- Provide senior leadership and direction for the Quality Control Department to ensure the attainment of corporate and local objectives.
- Develops, coaches, mentors staff to ensure business goals and development plans are met.
Leads a team of QC employees responsible for:
- Oversight and maintenance of laboratory systems and equipment
- testing of raw materials, components, in process and finished good product
Oversight of FPG plant operations including, but not limited to:
- manufacturing unit operations
- review / approval maintenance preventive maintenance changes;
- review / approval of critical equipment, systems, and utility issues and investigations
- establishes metrics to track and trend operations, as necessary.
- Establish current and long-range plans and objectives required to assure corporate and operational-level compliance.
- Assure all applicable quality processes are deployed and maintained in accordance with GxP, policies and procedures,
- Responsible for planning and budgeting pertaining to Quality Control activities.
- Ensures contracted third-party testing (CMOs and Labs) are in compliance with appropriate quality practices to meet the desired quality attributes of the Company and ensures the facilities/quality systems will pass regulatory inspections.
- Provides QC oversight and approval of cGMP QC documents (change controls, deviations, CAPAs, procedures, validation protocols, etc.).
- Lead projects or participates in projects related to the general area of QC’s responsibilities, and
- Understands and proposes improvements to Quality Systems to maintain compliance and improve efficiency utilizing risk-based methodologies.
- Ensures department training system (including GMP and on-the-job programs) are established and maintained to support regulatory and Company requirements,
- Coordinates laboratory activities and actively participates in regulatory agency inspections, notified third party audits, and customer audits.
- Monitor and assess emerging Quality and Regulatory requirements/issues and determine impact to the organization, and works to remediate any identified gaps or improvements.
- Performs other duties / projects as assigned by the Vice President, US Quality Assurance.
- Bachelor of Science and 15 years (or combination of MS with 12 years, PhD with 10 years) of experience in pharmaceutical QC operations for development through commercial products; biologics experience is highly preferred, small molecule experience is a must.
- Experienced in analytical / microbiology method development and validation, method transfer activities, and continuous improvement. This will involve oversight of GMP testing at CMOs as it applies to laboratory and stability functions.
- Solid experience with effectively managing FDA and other regulatory inspections, working with regulators, and vendor audits is essential.
- Experience with, and good understanding of, FDA and other key regulatory agency inspection procedures, inspection preparation and management, and addressing inspectional findings is also required.
- Full understanding of GMPs and the pharmaceutical development process is required as well as transfer of processes and methods from development to scale-up and scale-up to commercialization is necessary.
- Advanced knowledge of analytical and microbiology methods and testing required.
- Broad knowledge of risk-based Quality Systems’ components is required.
- MS Office applications, Trackwise, Oracle, Empower, LIMS is highly preferred.