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Associate Director, Gcp Compliance Lead, Deviation
vor 3 Monaten
About the role**:
As the Associate Director, GCP Compliance Lead, Deviation Management, Clinical Quality Assurance, you will establish standards for excellence in GCP investigation documentation, root cause analysis, responses, CAPAs, and effectiveness checks to optimize effective and consistent performance within Research and Development, Plasma Derived Therapies and Vaccines Business Unit.
You will lead investigations into systemic GCP quality issues, and ensure effective mitigations are established as well as interpret quality metrics and trends to identify and communicate compliance risks and liaise with business stakeholders to drive organizational process improvements.
You will also share lessons learned from investigations and ensure risk mitigations are established and sustained across the company.How you will contribute:
- Establish standards for excellence in GCP investigation documentation, root cause analysis, responses, CAPAs, and effectiveness checks to optimize effective and consistent performance within Research and Development, Plasma Derived Therapies and Vaccines Business Unit
- Lead investigations into systemic and/or crossprogram quality issues, scientific misconduct, and serious breach of GCP; facilitate identification of root cause and development of appropriate corrective and preventive actions; track actions and confirm effectiveness; ensure reporting of potential or confirmed violations to regulatory authorities.
- Interpret quality metrics and trends to identify and communicate compliance risks and liaise with business stakeholders to drive organizational process improvements.
- Share lessons learned from investigations and ensure risk mitigations are established and sustained across the company.
- Partner with business stakeholders on process improvement initiatives to ensure compliance with ICH GCP quality risk management and other regulatory requirements for clinical research.
- Escalate systemic and/or critical problems and recommend appropriate solutions to senior management for immediate and longterm resolution.
- Participate in GCP health authority inspections as well as in process improvement initiatives as requested by management.
- Provide professional expertise, strong leadership in GCP guidance and regulation as well as mentor and provide support to CQA personnel, as needed.
What you bring to Takeda:
- BA/BS degree required; advanced degree preferred.
- Minimum of 10 years of experience in the pharmaceutical, biotechnology or related health care industry.
- Minimum 7 years of GCP related Quality Assurance or Compliance related experience.
- Extensive knowledge and/or awareness of ICH GCP and applicable global regulations and guidance for clinical development
- Advanced knowledge in the management of quality events and GCP deviations, inclusive of conducting robust root cause analysis and developing CAPA plans that mitigate risks to the company, to safety and data integrity.
- Extensive experience in management of GCP quality event investigations
- Collaborative team player with a positive attitude and ability to think and act quickly to identify creative solutions to complex problems.
- Effective technical writing skills; able to write quality positions, quality event/deviation reports, and procedures.
- Excellent communication skills with ability to negotiate and influence without authority in a matrix environment.
- Strong judgment, project management and decisionmaking skills; able to manage multiple projects and demanding timelines.
- Superior attention to detail and ability to analyse complex data.
- GCP Quality Assurance registration/certification preferred.
- Routine demands of an officebased environment.
- Willingness to travel to various meetings and/or audits, including overnight trips. Some international travel may be required.
- Up to 10% travel.
More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do.
We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
Important Considerations:
At Takeda, our patients rely on us to deliver quality products.
As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product.
In this role, you may:
- Work in a controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body.
- No makeup, jewelry, contact lenses, nail polish or artificial
