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Astellas Pharma Director Pharmacovigilance Quality Assurance 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 .

This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.

Purpose and Scope:

The Director provides leadership and strategic direction to the Pharmacovigilance Quality Assurance (PV QA) Team which is responsible for QA oversight of Pharmacovigilance activities to ensure compliance with (inter)national regulatory requirements for Good Pharmacovigilance Practice (GPVP/GVP). This position will collaborate closely with Clinical & Research Quality Assurance (CRQA) peers and teams in other Astellas regions to provide comprehensive quality oversight and quality assurance for Astellas Pharmacovigilance activities.

Essential Job Responsibilities:

  • Contributes to the design and strategic direction of the PVQA oversight and support to the Astellas organization in collaboration with the CRQA Leadership Team and stakeholders locally, regionally and globally. Directs the development of this approach and its implementation to ensure an effective audit program which complies with regulatory requirements and stakeholder expectations is developed and executed.

  • Anticipates and proactively responds to trends and/or shifts in the external pharmacovigilance environment (e.g., Regulatory Agency, regulations, industry standards, customers) by assessing impact and ensuring robust Quality Systems meet these external requirements, trends and expectations.

  • Manages and directs the PVQA staff as assigned. Coordinates leadership, development, mentoring and support for direct reports as well as ongoing resource assessment. Responsible and accountable for the PVQA staff recruitment, development and performance management. Reviews and manages the PVQA training matrices for all roles.

  • Contributes to the planning and administration of the financial budget for PVQA activities by forecasting demand management for resources. Provides regular budget reports for global activities and adjusts information for interim forecasting based on changing business requirements.

  • Develops, manages and allocates resources for execution of the PV audit schedule for license partners, internal audits, vendors, etc. in conjunction with CRQA colleagues and stakeholders to ensure an effective audit program which complies with regulatory requirements and stakeholder expectations.

  • As assigned, act as Primary Inspection Administrator for the facilitation and management of regulatory agency inspections and customer/license partner audits. This includes management of preparation activities through response development and follow-up of commitments.

  • Provides leadership and guidance to the functional groups for significant issue management (deviation/CAPA). Ensures appropriate implementation of corrective actions and quality system improvements. Leads an effective escalation process for management of deviations, analysis of risk and measuring effectiveness.

  • Will be responsible to lead and coordinate PVQA-led initiatives, oversight of quality documents and assignment of risk-ranking activities annually for PVQA, including coordination of the PV Strategic Audit Plan. Drives new ideas and innovation to promote process improvement and risk mitigation to support Pharmacovigilance and overall Astellas' Quality Systems. Develops short and long-term risk-based quality strategies in support of pharmacovigilance activities and drives their implementation locally and globally as appropriate. Provides guidance, expertise and support to local and global PV project teams to ensure GPVP regulatory requirements are met.

Quantitative Dimensions:

  • This role functions as the QA main point of contact for Pharmacovigilance for their assigned region, and all PV license partners globally that interface with that region (or their delegate)

  • Responsible for managing internal and external resources to ensure all assigned audits per schedule are conducted

  • Annually, this role will globally coordinate and assign risk-ranking responsibilities, requests for PVQA support on projects/initiatives, and oversee coordination of auditor assignments for the annual schedule.

  • This role will serve as the primary delegate for the Head, PVQA, for formal review and approval of audit plans and reports across PVQA, as well as global invoices and other department expenses up to the level of DOA.

Organizational Context:

  • Serves as a leader within the PVQA team; in this capacity, is directly responsible for people management of Astellas employees an/or oversight of external/contract auditors.

  • Reports to Head, Pharmacovigilance QA

  • Peers include management levels within Clinical QA, Electronic Systems QA, Research QA and Quality Systems QA across the regions comprising CRQA

  • Collaborates, advises and provides consultation on quality matters impacting the PV system to individuals and Functional Management Teams across the Astellas organization

Qualifications:

Required

  • Bachelor's degree, with 12+ years of industry experience, 5-7 years of QA experience, and 3-5 years managing staff.

  • Experience in managing a Quality System within a GxP environment. Comprehensive knowledge of GxP and other regulations and understanding of global quality standards relating to product development, submission and/or commercialization.

  • Comprehensive knowledge of GxP and other regulations for pharmaceuticals and biologics and understanding of global quality standards and regulatory authority inspection trends relating to product development and submission, as well as commercialization. Demonstrated ability to establish local and regional Quality policies and to influence the development and implementation of global Quality policies in support of the quality system.

  • Excellent interpersonal, communication and presentation skills

  • Strong organization skills

  • Ability to initiate, build and maintain strong cross-functional and cross-divisional business relationships and positively influence key, strategic position holders across locations and functions.

  • Influencing skills with a demonstrated ability to lead projects, initiatives, and programs across multiple departments, regions and business units within Astellas and with external stakeholders.

  • Demonstrated ability to solicit input and liaise with stakeholders to prioritize and set strategic direction for change.

  • Demonstrated experience in hosting and facilitating regulatory agency inspections and customer/license partner audits with successful outcomes.

  • Comprehensive knowledge of GxP and other regulations for pharmaceuticals and biologics and understanding of global quality standards and regulatory authority inspection trends relating to product development and submission, as well as commercialization.

  • Demonstrated ability to establish local and regional Quality policies and to influence the development and implementation of global Quality policies in support of the Quality Management System.

  • Demonstrated ability to translate external and internal quality and compliance trends into QA practice and to disseminate relevant data to the larger organization to further enhance overall quality and compliance levels.

  • Demonstrated competence to resolve with decision making responsibility complex and diverse problems that have a significant impact within CRQA and across Astellas.

  • Demonstrated experience leading strategic development and successful execution of plans and initiatives for addressing complex and diverse QA matters with minimal management oversight.

  • Demonstrated people management, staff development and leadership skills

  • Demonstrated ability to effectively work within a global environment.

Preferred

  • Advanced degree is preferred.

  • Quality assurance / auditing certification or credentials through recognized quality standards organization is preferred.

Benefits:

  • 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

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Category Quality Assurance/Quality Control

Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans

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