Astellas Pharma Manager/Senior Manager, Pharmacovigilance Quality Assurance (PVQA) in Northbrook, Illinois
Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com.
Purpose & Scope:
The primary focus of this position is to contract and manage resources responsible for assessing processes at Astellas, and any contracted service providers to ensure that systems, policies and procedures comply with national and international requirements for the pharmacovigilance function and the collection and reporting of safety information. This comprises both auditing as directed, and consultancy activities and related control of cost and financial aspects. This role develops and manages a sub selection of the quality system and operations across region. As QA Expert, provides QA consultancy (Identifying risk, leading continuous improvement) services to the organization for the Pharmacovigilance and related functions. This role will coordinate the preparation, the conduct and the follow up of Regulatory Inspections as directed.
Essential Job Responsibilities:
Execution of regional, cross regional and/or global multiple audit programs. This includes the planning, conducting and reporting of audits, liaising with customers on audit findings and the follow up thereof. It also incorporates interpretation of findings, providing trending information, root cause analyses and identifying lessons learned for Astellas organization continuous improvement. Lead the proper management and follow up of the findings and improvement areas.
Provide unsupervised GPvP expert advice to key personnel. This includes and is not limited to:
developing training materials and providing GPvP training internally and externally to both small and large professional organizations. It also encompasses coaching of QA colleagues and other functions, on QA related processes
reviewing of the responses/communication provided to health authorities (e.g. in case of inspection)
interpreting health authorities' requirements and advising in their implementation across Astellas organization
Responsible for preparation of the different Astellas entities and or partners to any regulatory inspection. Analyze the risks, propose the strategy for readiness and manage the implementation of readiness program across the departments and the territories ensuring harmonized approach.
Work with the PVQA leadership in identifying needs for outsourcing, selecting, managing and evaluating 3rd Party QA service providers to which audit and/or consultancy activities are being outsourced. This includes providing training, managing financial information and maintaining effective interfaces to ensure that output meets defined expectations in terms of content and timelines.
Support the development, improvement and maintenance of the Astellas Quality System by signaling root causes to non-conformances related to the system, by addressing observed gaps in the system.
Manage Quality Issues related to critical non conformities, serious misconduct and potential fraud. Lead proper corrective and preventive actions identification and roll out and ensure follow up with effectiveness measures.
Develop, analyze and report relevant key performance indicator information.
Manage GxP inspections. This includes communication with Regulatory authorities, Inspection preparation, hosting, support of CAPA generation and monitoring of follow up to ensure that any risk / non -conformance as identified by inspectors is adequately addressed and mitigated.
Develop and manage interfaces with QA departments of service providers, to ensure QA oversight of the service provider and that any risk to Astellas business is being mitigated.
Managing audit programs which approximately contain between 15-30 Audits annually, depending on complexity.
Approximately 50% of time is spent in the audit role and an equal amount in the consultancy role and other QA related activities.
Frequent national and international travel (up to 25%).
Contribute to the management of the financial information on outsourced audits for individual audits involving the use of contract auditors.
Frequent Presentations on GPvP, Audit Results and Process Improvement on average once per month.
Frequent, monthly PVQA Departmental Meeting with direct QA colleagues.
Reports to (Associate) Director PVQA
Frequest contacts with R&D departments VPs and delegates: clinical operations, Data Science, Pharmacovigilance, Clinical Pharmacology, Bioanalysis, Medical Affairs, IT, IGD, Regulatory Affairs.
Frequest contacts with CRQA departments (Clinical QA, Quality Operations, Research QA).
Auditees: CROs/vendors/service provides (senior management, project management, QA, functional team personnel, license/business partner personnel, in addition to internal Astellas staff.
Represent PVQA on and contributes to M&D- and/or CRQA projects as assigned.
Seven (7) years' experience in clinical/Pharmacovigilance QA, or in the pharmacovigilance function.
Excellent knowledge of QA Standards, particularly Good Clinical and or GPvP Practice Guidelines and Regulations and other related areas as specific for the function (e.g. PV), as well as basic legal regulations.
Very good interpersonal and communication skills.
Ability to influence without authority.
Project Management Skill.
Excellent attention to details.
Flexibility and Adaptability.
Advanced degree is preferred.
Quality assurance / auditing certification or credentials through recognized quality standards organization is preferred.
Medical, Dental and Vision Insurance
Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down
401(k) match and annual company contribution
Company paid life insurance
Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
Long Term Incentive Plan for eligible positions
Referral bonus program
Category Clinical and Research Quality Assurance (CRQA)
Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans