QA Director (BB-FB78A)
Found in: Neuvoo Bulk CN
Responsible for the Quality oversight and batch disposition activities for the production of clinical and commercial drug product lots in support product development, clinical supplies, regulatory submissions, and commercial supply.
Provide Quality oversight for material (and component) suppliers and third party manufacturers (TPM) utilized in the production of development, clinical, and commercial products.
Oversee clinical quality assurance activities to ensure the conduct of clinical studies, and their outputs, comply with GCPs and Ferring policies and procedures.
Oversee all surveillance processes including planning, execution and generation of reports for internal and external audit programs. Prioritize and communicate findings to audited sites and escalate significant issues to executive management. Compile all audit findings and monitor for signals and trends
Responsible for the deployment and reporting of comprehensive Quality metrics
Ensure company and departmental training system (including GMP and GCP programs) are established and maintained to support regulatory and Company requirements.
Manage the product quality complaint process, including assessment of Field Alert Reporting (FAR) and recall determination
Primary contact with CFDA for product recalls; chairs the Local Recall Committee and primary contact with the Global Recall Committee.
Primary contact and leads all Health Authority and regulatory inspections; insures inspection readiness at all times.
Actively participates in Ferring due diligence initiatives providing Quality subject matter expertise and works cross functionally to meet project deliverables.
Monitor and assess emerging Quality and Regulatory requirements/issues and determine impact to the organization.
As Management Representative, with the authority and responsibility to:
• Ensure that processes needed for the QMS are established, implemented and maintained,
• Ensure the promotion and awareness of customer, regulatory, and statutory requirements throughout the organization,
• Report to executive management on the performance of the QMS, including needs for improvement,
• Report appropriate issues concerning the QMS to executive management for resolution and consideration for any further action, and
• Ensure processes are in place to allow for communication with external parties on matters relating to the QMS
Lead projects or participate in projects related to the general area of QA’s responsibilities
Ensure GxP documentation is established, approved and issued following the written procedures. Finally approve the specific documents and reports according to the procedures requirements.
- Minimum of a Bachelor of Science degree in biochemistry, chemistry, or pharmacy from an accredited college or university.
- A minimum of fifteen (15) years of medical device, pharmaceutical or biopharmaceutical industry experience with at least ten (10) years of progressive Quality Management System and leadership experience including: QC laboratory operations and manufacturing operations oversight is required.
- Direct experience working in at least two of the following cross functional areas is highly preferred: Validation, Manufacturing, Technical Services, Plant Management, or Quality Control.
- MS Applications, Trackwise, MiniTab
- Fluent English and Chinese (written and verbal communications)
- Excellent leadership and communication skills with the ability to effectively promote and manage change.
- Excellent problem-solver with the ability to make difficult decisions under challenging circumstances.
- In-depth knowledge of GxP (CFDA GxP, US 21CFR 210, 211, EU GMP), ICH, ISO, QSR and other applicable international regulations, standards, Directives and Guidance.
- Strong background in oral solids pharmaceutical products, and aseptic manufacturing processes for sterile pharmaceutical products and drug-device combination products related to development and commercial programs.
- Strong background in developing quality objectives through effective quality planning.
- Ability to build and implement an effective quality management system.
- Ability to effectively coach, mentor and develop staff.
- Ability to educate stakeholders, customers and management.
Location:Ferring China M&S
Ferring Pharmaceuticals is a research-driven, specialty biopharmaceutical group committed to helping people around the world build families and live better lives. Ferring is a leader in reproductive medicine and women’s health, and in specialty areas within gastroenterology and urology. Ferring employs approximately 6,500 people worldwide, has its own operating subsidiaries in nearly 60 countries and markets its products in 110 countries. Learn more at www.ferring.com and @Ferring, or connect with us on Facebook, Instagram and LinkedIn.
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