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Astellas Pharma Senior Vendor Management Manager, 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:

Responsible for managing the QA vendor oversight program for vendors used by Astellas for GxP regulated activities (including Medical and Development (M&D), Astellas affiliates, and Commercial), to ensure compliance with regulations in Good Clinical Practice, Good Pharmacovigilance Practice, Good Laboratory Practice, Good Manufacturing Practice, and Electronic Records Electronic Signatures (ERES) and Electronic Systems/Computerized System Validation (CSV). Defines, implements and executes the QA vendor audit strategy and leads QA Vendor Management to ensure that vendors used by Astellas for GxP regulated activities are assessed using risk ranking methodologies and are subject to quality evaluations.

The role is responsible for selecting and managing companies performing outsourced services on behalf of QA.

Contributes to the development, implementation, and successful execution of the QA mission, objectives and the Corporate Strategic Plan

Essential Job Responsibilities:

  • Responsible for the development, implementation and execution of the QA vendor audit strategy and procedures in close collaboration with all QA functions.

  • Serves in a leadership role in the creation of the vendor audit schedule based on service tier and risk rating, in compliance with the pre-defined QA Vendor Management policy and procedure. Collaborates with QA and appropriate Astellas business functions to ensure that all GxP regulated vendors are evaluated per the vendor audit strategy. Communicates vendor qualification status to the Astellas organization and regulatory authorities upon request.

  • Responsible for oversight of annual Audit Schedule completion for vendor audits, for evaluating new vendors or vendor services being used by the business during the fiscal year, and for evaluating vendor performance with various stakeholders in the Astellas organization.

  • Serves in a leadership role in selecting and managing contract auditing companies and their staff, contracted by QA to conduct audits and trainings on their behalf, or to provide quality consultancy services. Responsible for overseeing contract auditing company's compliance with contract terms. In collaboration with QA-MT members, provides outsourcing forecasts to CAC.

  • Maintains a state of Inspection Readiness: ensures that vendor auditing complies with defined audit strategies, is supported by quality documentation, and is maintained in the audit management system.

  • Responsible for implementing a standardized process to establish and maintain contracts with contract auditing companies. Ensures standardization of contracted activities across the various auditing companies and seeks opportunities for cost-effectiveness. Drives contract negotiations in collaboration with R&D Procurement.

  • Responsible for supporting the conduct of high profile/niche vendor audits including for-cause vendor audits.

  • Represents QA in GxP regulated vendor selection projects globally. Provides quality requirements and evaluates potential vendors against these quality requirements.

  • Represents QA in Functional Service Provider oversight bodies.

  • Responsible for forging strong collaborative relationships with internal QA key stakeholders and functions, and with relevant external stakeholders within the Astellas organization.

  • Actively maintains knowledge on current developments in vendor management within the pharmaceutical industry and trains QA staff in vendor auditing.

Quantitative Dimensions:

  • Monitors and assigns risk ratings for > 350 GxP regulated vendors used by Astellas

  • Manages 10-15 contract auditing companies

  • Forecasts and monitors spend for >50 outsourced audits

  • Supports conduct of 4-8 high profile/niche vendor audits per annum

Organizational Context:

  • Reports to the Associate Director Vendor Management.

  • Peers include Sr Managers and Associate Directors within QA and across all Astellas functions.

  • This is a key leadership role reinforcing vendor oversight throughout the organization. No direct reports; however, strong leadership and communication skills are critical for success as this position interacts with various levels of personnel throughout Astellas and with contracting company staff. Additionally, oversight of 1-2 contractors may be required to support vendor management activities as needed.

  • Collaborates, advises and provides consultation on vendor management and vendor compliance to individuals, study/core teams, R&D Procurement staff and Functional Management Teams across the Astellas organization.

  • Collaborates directly with L2 and L3 level staff in QA and applicable Astellas business functions.

Qualifications:

Required

  • Bachelor of Science degree.

  • Minimum of 7 years of experience in the pharmaceutical, biotechnology, or related industry.

  • Minimum of 4 years of significant experience in auditing and vendor relations.

  • Proven experience with GxP (GCP, GVP, GLP, CSV, and/or GMP), Quality Management Systems and quality support including quality oversight of vendors providing GxP regulated services.

  • Minimum 4 years people/project management experience, preferably in a highly matrixed, multicultural global setting, requiring facilitation, negotiation, problem-solving, and conflict resolution skills.

  • Expert knowledge of the pharmaceutical and/or CRO industry and of pharmaceutical R&D processes.

  • In-depth understanding of GxP requirements for both investigational and marketed products.

  • Strong hands-on experience and understanding of Vendor Management as applied throughout the entire pharmaceutical compound/product life cycle.

  • Proficiency in Microsoft Office and MS Project.

Skills and competencies:

  • Effective interpersonal skills and multi-cultural /intercultural awareness; able to negotiate and build consensus for plans and priorities and able to develop effective relationships through collaboration. Forges strong working relationships with all colleagues and stakeholders.

  • Excellent oral and written communication as well as presentation skills in English.

  • Demonstrated ability to proactively predict and resolve complex problems, thinks strategically and tactically, generates solutions to complex problems and builds consensus across the global organization. Able to generate insights and leverage learnings at the individual, team and functional level.

  • Advanced leadership skills; communicates and demonstrates vision and commitment.

  • Domestic and international travel at 10-15% is required.

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 Accounting/Finance

Astellas is committed to equality of opportunity in all aspects of employment.

EOE including Disability/Protected Veterans

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