Director, Local Operating Company Quality Assurance - United Kingdom
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- Provide Quality Assurance oversight of Local Operating Companies (LOCs), including planning and execution of Good Clinical Practice (GCP) and Pharmacovigilance (PV) audits.
- Ensure implementation of global standards and procedures.
- Supports regulatory inspections and partner audits of LOCs.
- This position has overall responsibility for the ongoing development and operational success of the LOC functions responsible for GCP- and GPvP.
- This includes alignment of LOC initiatives, goals and activities with PDD QA goals.
- Provide direction to the Local Operating Company (LOC) functions responsible for clinical and post-marketing studies and pharmacovigiliance activities to ensure the implementation of strategies regarding the processes, procedures and quality standards required to maintain compliance with applicable regulations.
- Ensure patient safety and data integrity.
- Analyze audit program results, quality issues and investigations in order to optimize LOC operations and overall state of compliance.
- Ensure that activities are conducted and reports written according to applicable SOPs and regulations.
- Ensure that LOCs are fully prepared for regulatory inspections of GCP- and GPvP-regulated activities.
- Provide on-site support and guidance during regulatory inspections.
- Provide strategic organizational direction to assure that inspection responses are timely and appropriate to maintain company’s good standing with regulatory agencies.
- Interpret and assess impact of emerging changes to local and international regulations and guidance, and oversee implementation.
- Establishes key relationships within our company to assist in identification of changes in the regulatory environment and impact on LOCs.
- Remain current with industry trends and draft regulations/guidance.
- Work in collaboration with PDD Global Compound Compliance and PDD Quality Systems to to identify and mitigate GCP/PV quality and compliance issues with potential impact across multiple products,or functional groups.
- Drive collection and analysis of LOC metrics relating to GCP and GPvP regulated activities and identify and lead continuous improvement initiatives. Collaborate with Global Quality Services to provide LOC report card.
- Collaborate with the PDD Global Compound Compliance, PDD Quality Systems, PDD Global Quality Services and other global company entities to provide a consistent quality approach, including:
- Develop and present periodic reports describing compliance trends and identifying areas of potential risk to senior management.
- Ensure that GCP/PV QA audit strategy for LOCs is harmonized with other PDD regions.
- B.S. in Biology, Nursing, Pharmacy, or related scientific field. MS preferred.
- Extensive experience in the pharmaceutical, GCP- and/or GPvP related Quality environment.
- Solid knowledge of people and process management experience in GCP and/or GPvP Quality Assurance including senior level project planning/budget management.
- In-depth knowledge of the applicable GxP and GPvP regulations and guidances and ICH Guidelines.
- Demonstrates advanced knowledge in the conduct and reporting of audits and the translation of findings into corrective actions plans that mitigate risks to the company, to safety and data integrity.
- Clinical Development: Understands the phases, processes and techniques used to execute a clinical development program.
- Understands the medical/therapeutic impact of products.
- Possesses the necessary science education and knowledge to provide QA oversight of clinical trials and pharmacovigilance activities, and to assure ethical treatment of subjects. Understands medical terminology and is familiar with standards of care and disease states.
- Demonstrates strong leadership skill and the ability to influence others.
- Risk management expertise, including issue identification, problem solving, decision making, and risk mitigation.
- Demonstrates proficiency in negotiation and conflict resolution.
- Must professionally, clearly, concisely and consistently communicate to external and internal customers via phone, e-mail, fax, and written documents.
- Must also be able to demonstrate professional presentation skills deliver fair balanced presentations and, when applicable, facilitate resolution of differing opinions.
- Must demonstrate proficiency in managing complex projects, delivering all expected deliverables in a timely manner, and proactively communicating changes in pre-established goals and deadlines.
- Organizational skills: Must be able to prioritize work effectively to meet timelines.
- Interpersonal: Must be able to adapt to other personalities in a respectful manner that is conducive to goal achievement and team building.
- Computer skills: Must be able to efficiently utilize the computer hardware and software programs provided to plan, manage, conduct and track deliverables and to communicate with internal and external team members.