Document Control Manager oversees document and record control operations, policies, and procedures for the secure management and access of company information assets. Establishes security protocols for the access, storage, backup, maintenance, reproduction, protection, and disposition of all documents. Being a Document Control Manager evaluates media formats and recommends storage requirements to protect and secure records/information. Develops and manages access and control procedures to comply with requirements for varying levels of security classifications specified by the governing authority. Additionally, Document Control Manager maintains auditing, monitoring, and change control systems to ensure document integrity, quality, and version control. Typically requires a bachelor's degree. May require security clearance. Typically reports to a director. The Document Control Manager manages subordinate staff in the day-to-day performance of their jobs. True first level manager. Ensures that project/department milestones/goals are met and adhering to approved budgets. Has full authority for personnel actions. To be a Document Control Manager typically requires 5 years experience in the related area as an individual contributor. 1-3 years supervisory experience may be required. Extensive knowledge of the function and department processes. (Copyright 2024 Salary.com)
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 at our Westborough, MA site. This is an onsite position.
Purpose and Scope:
The Manager, Quality Assurance Document Control (QADC) role oversees the daily operations of the GMP QA Document Control team. This position directly supports ongoing manufacture of biological preclinical and clinical trial materials by providing timely and compliant document issuance, reconciliation, and document implementation support.
Essential Job Responsibilities:
Provides coaching, mentoring, professional development, and performance management to junior Quality Assurance staff as appropriate.
Quantitative Dimensions:
This position will regularly operate in a time-sensitive environment, with direct impact on the ability to sustain key manufacturing activities and provide value to patients in need.
Organizational Context:
Reports to the Senior Manager of Quality Assurance Operations. Directly manages training specialists and collaborates closely with both cross-functional and QA peers.