Sr. Manager to Associate Director, QA Pharmacovigilance (PhV)

at  Incyte Corporation

Overview:
Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value.
The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules.
Job Summary:
The Sr Manager to Associate Director QA PhV will play a lead role in the QA oversight and assessment of GVP activities to ensure robust systems and processes for global Pharmacovigilance (PhV) activities. The person in this role acts as GVP Quality advisor and collaborates with Global PhV departments and other relevant departments/functions interfaced with PhV activities (e.g. Global Regulatory Affairs, US Medical Affairs,…).
This job will include the execution of lncyte QA PhV audits and the provision of PhV guidance and advice across relevant Post-marketing and Development areas.

Essential Functions of the Job / Duties and Responsibilities

• Assist in the development of and execution of the GVP audit program (Processes, affiliates, vendors, business partners and all others relevant structures/functions identified).
• Participate to the maintenance of the PhV Quality Management System including QA support for PhV supplier qualification, change control, deviations, review of SOPs with ensuring continuous process improvement.
• Establish robust collaboration with PhV Leaders and team members from various safety functional areas, (PhV Operations, Risk Management and Safety Surveillance, PhV Systems, PhV compliance, …) by providing efficient QA support.
• Contribute and review of key pharmacovigilance documents, e.g. PSMF, QPPV meeting presentation and other regulatory safety documentation, as needed.
• Support the preparing, coordinating and hosting Inspections/Partner audits in collaboration with the PhV functions.
• Coordinate responses and corrective/preventative actions from audits and regulatory inspection findings.
• Establish robust collaboration with other US/NA Non-PhV functions (US/CAN Medical Affairs, NA Medical Information, Commercial teams ….) in order to ensure robust systems and processes in place for safety aspects.
• Stay abreast of Pharmacovigilance and Safety regulations, US & CAN regulations, ICH GCP, and guidelines from other regulatory agencies for the management of safety post-marketing and safety clinical trials, as appropriate.
• Escalate to Global QA Clinical/PhV Management of internal and external serious non-compliance/deviations in a timely manner.
• Involve in other regulatory authority GxP inspections based on level of expertise and experience, as assigned.
• Assist with the management of QA consultants performing audits on behalf of lncyte Corporation.
• Foster a relationship of trust and effective communication with functional stakeholder and within the Global QA team.

Qualifications / Requirements

• Minimum Bachelor’s degree in a science or healthcare related discipline, or similarly conferred degree from a University.
• 5 - 10 years’ experience in a pharmaceutical or bio-pharmaceutical company in a QA PhV role with a minimum of 2 years’ lead auditor experience performing GVP compliance audits of vendors, business partners and/or internal systems/department.
• Ability to travel a minimum of 30%.
• Prior GVP inspection experience preferred.
• Thorough knowledge in GVP and global regulatory requirements.
• Strong Interpersonal skills, including organizational sense, rational and autonomy.
• Strong verbal and written communication skills with well-structured communication and presentation ability.
• Results focused which may require negotiating skills and diplomacy.
• Knowledge of other languages is an asset.

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.
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• Assist in the development of and execution of the GVP audit program (Processes, affiliates, vendors, business partners and all others relevant structures/functions identified).
• Participate to the maintenance of the PhV Quality Management System including QA support for PhV supplier qualification, change control, deviations, review of SOPs with ensuring continuous process improvement.
• Establish robust collaboration with PhV Leaders and team members from various safety functional areas, (PhV Operations, Risk Management and Safety Surveillance, PhV Systems, PhV compliance, …) by providing efficient QA support.
• Contribute and review of key pharmacovigilance documents, e.g. PSMF, QPPV meeting presentation and other regulatory safety documentation, as needed.
• Support the preparing, coordinating and hosting Inspections/Partner audits in collaboration with the PhV functions.
• Coordinate responses and corrective/preventative actions from audits and regulatory inspection findings.
• Establish robust collaboration with other US/NA Non-PhV functions (US/CAN Medical Affairs, NA Medical Information, Commercial teams ….) in order to ensure robust systems and processes in place for safety aspects.
• Stay abreast of Pharmacovigilance and Safety regulations, US & CAN regulations, ICH GCP, and guidelines from other regulatory agencies for the management of safety post-marketing and safety clinical trials, as appropriate.
• Escalate to Global QA Clinical/PhV Management of internal and external serious non-compliance/deviations in a timely manner.
• Involve in other regulatory authority GxP inspections based on level of expertise and experience, as assigned.
• Assist with the management of QA consultants performing audits on behalf of lncyte Corporation.
• Foster a relationship of trust and effective communication with functional stakeholder and within the Global QA team