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 Westborough, MA.
Purpose and Scope:
The Quality Systems Engineer role participates in the development and execution of key compliance
functions within the larger GMP Quality Assurance department. This position indirectly supports
ongoing manufacture of biological clinical trial materials by providing timely and compliant support for
quality systems including Change Control administration, Calibration / Validation review, MasterControl
system administration and workflow development, inspection management and hosting, internal
auditing, supplier management, site Quality Council, quality metrics generation, and other site-level
compliance deliverables.
Essential Job Responsibilities:
Assists with the management and administration of the GMP Change Control program. Assists users with navigating the change control decision tree and developing comprehensive change requests. Follows up on action items and assists with change request closure and efficiency review.
Performs select technical review as needed, including review of calibration records, executed validation protocols, supplier audit responses and change notices, and other content as appropriate.
Assists with the generation of quality-facing monthly metrics for distribution to Technical Operations and Quality Assurance management, and for review by the Quality Council.
Assists with internal audit tracking and scheduling. Coordinates scheduling of lead auditors, co-auditors, and auditees. Tracks audit responses and commitments.
Assists with supplier management program, facilitates Raw Material Risk Assessments for new and changing materials and helps maintain Supplier Audit schedule. May participate in supplier audits and / or tracking of supplier audit commitments.
Becomes a resource proficient in aseptic cell culture manufacturing and provides consultation on quality considerations related to aseptic biotechnology manufacturing.
Supplies management with relevant compliance insights; highlights and engages continuous improvement opportunities.
Quantitative Dimensions:
This position will provide a direct and positive impact on the compliance of the equipment, facility, methods, and systems supporting current and future AIRM manufacturing processes. AIRM processes will be compliant with strict international regulatory standards and meet Astellas' uncompromising focus on Quality and Integrity.
Organizational Context:
Reports to the Manager of Quality Systems. Serves as part of the larger GMP Quality Assurance department at AIRM.
Qualifications:
Required
BA/BS or equivalent with 3+ years or Master’s degree with 0-2 years of proven experience
In lieu of a Life Sciences degree, consideration will be given to candidate with minimum of 6+ years of relevant industry experience in biotechnological and/or pharmaceutical quality assurance and/or quality engineering
Proficiency with most major elements of job description, direct experience with at least one major area
Proficiency in major compliance regulations and consensus standards including 21CFR §11, §210, §211, §1271; Eudralex Volume IV (including ATMPs), ICH Q9, Q10, etc.
Strong proficiency in MS Word, Excel, PowerPoint, to include basic formulas, and creation/formatting of charts and data tables.
Preferred
Experience with the MasterControl electronic Quality Management System
Experience with supplier and/or internal audits
Solid understanding of cell culture manufacturing platforms
Comfort communicating data, facilitating meetings with senior partners, and maintaining minutes of key decisions and outcomes
Experience in an environment subject to regulatory audits
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
*LI-JB1
Category Institute for Regenerative Medicine
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans