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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:
Manages and grows the QA Document Control team responsible for administration of the cGMP Documentation program. This includes document issuance / reconciliation; SOP implementation, periodic review, and obsoletion; organization and management of critical cGMP documentation in the QA file room; and oversight of Astellas's records and information management program at the AIRM location. Provides real-time document consultation to cross-functional stakeholders at an aseptic cell culture manufacturing facility.
Collaborates closely with GMP department managers at the AIRM location to determine document needs, establish, and improve necessary document templates, and guide QADC staff to support project needs and maintain site compliance with good documentation practices and cGMP data integrity requirements.
Partners with functional areas to conduct periodic review of existing cGMP procedures.
Oversees the QA Document Control and GMP records and information management functions. Ensures adequate systems are in place to achieve and maintain records retention compliance pursuant to Astellas policies and regulatory requirements.
Supplies regular metrics to management with relevant compliance insights, highlights and engages in continuous improvement opportunities.
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.
Qualifications:
Required
BS degree in Engineering, Chemistry, Biological Sciences or equivalent with 8+ years or MS with 6+ years related experience in bio-pharma industry, and 2+ years of managerial experience in a cGMP compliance environment.
Demonstrated experience with developing or delivering training to colleagues and/or managing a training program and LMS.
Fluency in GMP documentation fundamentals, document administration, and data integrity principles.
Working knowledge of predicate regulations and industry consensus standards, including 21CFR §11, §210, §211, §1271; Eudralex Volume IV (including ATMPs), ICH Q9, Q10, etc.
Experienced in identifying, proposing, and managing quality system improvement initiatives and projects.
Advanced proficiency in MS Word, Excel, and PowerPoint
Preferred
Experience participating in, preparing for, and/or hosting external regulatory audits.
Background or prior coursework in Cell Biology, basic biological principles, and/or Visual Basic for Applications.
Experience with MasterControl, TrackWise, Veeva, or other eQMS.
Working knowledge of MS Visio and MS Project.
Experience supervising and coaching subordinate leaders to achieve organizational results
Benefits:
Medical, Dental and Vision Insurance
Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
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 Development QA
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans