Quality Services Document Control Manager - #197263

Astellas Pharmaceuticals


Date: 06/08/2022 11:00 AM

City: Long Lake, Illinois

Contract type: Full Time

Work schedule: Full Day

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:



  • Supports three or more of the Electronic Document Management Systems (EDMS) processes and Quality Systems (TrackWise for nonconformances/CAPA management).


  • Assures Astellas compliance with applicable global regulations, corporate standards and SOPs for Quality Systems and serves as a compliance resource to other Astellas Employees.


  • Serves as the QA RIM business liaison.



Essential Job Responsibilities:



  • Subject Matter Expert for three or more of the Document Management system processes and Quality Systems (TrackWise for nonconformance/CAPA Management).


  • Executes and manages tasks associated with the Quality Systems and applicable database including generating and evaluating information appropriately. Generates status reports and relays analysis to Senior Management Team as appropriate.


  • Utilizes technical skills and tools effectively to identify & resolve issues, ensuring risk evaluation completed and implementing solutions as appropriate.


  • Generates, interprets and responds appropriately to metrics related to Quality Services and supports KPIs.


  • Participate and contribute to Quality Services meetings and conferences and resulting actions.


  • Serves as the QA Records Management Business Liaison.


  • Assist the Associate Director in conducting strategic assessments (i.e. gap analysis) of quality metrics.


  • Maintain a working knowledge of latest regional and global regulations pertinent to Quality Systems and document management.


  • Where requested, participate in global projects related to global QA activity.


  • Other such duties as may be reasonably required by the business.



Quantitative Dimensions:



  • Support for regulatory agency inspections and internal/external audits to be less than 15 per year, including affiliates.


  • Supports the maintenance and improvement of the Astellas EDMS containing more than 3000 documents.


  • No budgetary or headcount responsibilities.



Organizational Context:



  • Reports to Associate Director, Quality Systems Document Control and Administration.


  • Based at the US Headquarters in Northbrook, Chicago


  • Internal Customer relationships


  • Employees at all levels.


  • Global QA colleagues


  • EHQ/US HQ colleagues at all levels


  • Other functions such as QA, PV, Legal, Operations, Regulatory, Medical, Affiliates and Pharmaceutical Technology


  • External customer relationships


  • All Health Authorities


  • External suppliers and consultants


  • Professional and Regulatory bodies (relevant to GMP/GXP)



Qualifications:


Required



  • BA/BS degree with a minimum of 3 years industry experience, preferably in a multicultural, global setting, requiring facilitation, negotiation, problem-solving, and conflict resolution skills.


  • In depth knowledge of GMP regulations, combined with broad knowledge of quality principles required.


  • Understanding of global GxP requirements/directives and awareness of different product types.


  • Proven GMP experience within a manufacturing facility or corporate QA function.


  • Good organizational, coordination, negotiation, presentation and communications skills.


  • Demonstration of Astellas Manager Competencies; typically, Level 3 to effectively earn the respect of QA colleagues and line management and request direction and support from line management when needed. (refer to competency matrix)


  • Fluency in written and spoken business English. Must be able to represent the company to external stakeholders.


  • Understanding of European regulatory environment.


  • Precise, rigorous and reliable with an analytical mind and attention to detail.


  • Anticipation and sound decision-making skills.


  • IT literacy including experience with information management systems to log track and trend applicable Quality Systems.


  • Full availability during business hours to respond to significant quality issues including flexibility for significant issues which may arise from time to time outside normal working day.



Preferred



  • Proficient in Microsoft tools, TrackWise and Veeva Vault Quality.


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



#LI-SS


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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