Astellas Pharma Senior Vendor Management Manager in Northbrook, Illinois
Developing innovative therapies is one of the most challenging, most essential and personally rewarding fields in science. This is the most exciting time to be a part of Astellas, a company with a uniquely collaborative and patient-focused culture.
There's something special about working at Astellas. It's reflected in our focus on the people we serve, the way we treat each other and the results we achieve together as a company.
Astellas is announcing a Senior Vendor Management Manager opportunity in Northbrook, IL.
PURPOSE & SCOPE:
Responsible for managing the CRQA vendor oversight program for vendors used by Medical and Development (M&D) and Astellas affiliates, to ensure compliance with regulations in Good Clinical Practice, Good Pharmacovigilance Practice, Good Laboratory Practice and Electronic Records Electronic Signatures. Defines, implements and executes the CRQA vendor audit strategy and leads CRQA Vendor Management to ensure that vendors used in MD 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 CRQA.
Contributes to the development, implementation, and successful execution of the CRQA mission, objectives and the 3-5 year strategic plan.
ESSENTIAL JOB RESPONSIBILTIES:
- Responsible for the development, implementation and execution of the CRQA vendor audit strategy and procedures in close collaboration with all CRQA functions.
- Serves in a leadership role in the creation of short term and long term vendor audit schedules based on risk ranking, in compliance with the pre-defined audit strategy. Collaborates with CRQA and M&D functions to ensure that all M&D vendors are assessed per the vendor audit strategy, including vendors used at the Astellas affiliates. Communicates vendor qualification status to the M&D organization and regulatory authorities upon request.
- Responsible for oversight of Annual Audit Schedule completion for vendor audits, for evaluating and approving of requests for additional vendor audits during the fiscal year and for evaluating vendor performance with various stakeholders in the M&D organization.
- Serves in a leadership role in selecting and managing contract auditing companies and their staff, contracted by CRQA to conduct audits and trainings on their behalf, or to provide quality consultancy services. Responsible for overseeing contract auditing company(s) compliance. In collaboration with CRQA-MT members, provides outsourcing forecasts, and provides accurate audit budget forecasts to CRQA-LT members. Ensures availability of a pool of qualified external QA resources and is responsible for training of external QA resources.
- Maintains a state of Inspection Readiness: ensures that vendor auditing complies with defined audit strategies, is supported by quality documentation, and that external staff training status is up to date, documented and readily available.
- 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 Portfolio Relationship ad Sourcing Management (PRSM)
- Responsible for the conduct of high profile/niche vendor audits including for-cause vendor audits.
- Represents CRQA in M&D vendor selection projects globally. Provides quality requirements and evaluates potential vendors against these quality requirements.
- Represents CRQA in Functional Service Provider oversight bodies.
- Responsible for forging strong collaborative relationships with internal CRQA key stakeholders and functions, and with relevant external stakeholders within the M&D organization, including relevant affiliate staff.
- Actively maintains knowledge on current developments in vendor management within the pharmaceutical industry and trains CRQA staff in vendor auditing.
Monitors and assigns risk ranking for > 350 vendors used by the M&D organization and 40+ Global Astellas affiliates
Manages 10-15 contract auditing companies
- Forecasts and monitors spend for >50 outsourced audits
- Conducts 4-8 high profile/niche vendor audits per annum
- Reports to the Director Vendor Management.
- Peers include Sr Managers and Associate Directors within CRQA.
- 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, PRSM staff and Functional Management Teams across the Astellas organization.
- Collaborates directly with L2 and L3 level staff in CRQA and M&D.
- Minimum 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), 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 & 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.
- The preferred location for this position is Northbrook (IL) United States or Leiden, Netherlands
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled
Category Clinical and Research Quality Assurance (CRQA)