Quality Systems Engineer

AIRM has a world-class R&D team, and is pursuing a diverse range of disease indications, ranging from macular degeneration (currently in clinical trials) and other ocular indications to vascular and autoimmune disease. AIRM's intellectual property portfolio includes pluripotent stem cell platforms -both embryonic and induced pluripotent stem cells as well as other cell-based therapy research programs. AIRM is headquartered in Massachusetts.

Astellas is announcing a Quality Systems Engineer opportunity at their Astellas Institute of Regenerative Medicine (AIRM) site in Westborough, MA. The is an onsite position.

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, Master Control system administration and workflow development, inspection management and hosting, internal auditing, supplier management, site Quality Council, quality metrics generation, and 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.

Organizational Context:

Reports to the Manager of Quality Systems. Serves as part of the larger GMP Quality Assurance department at AIRM.

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 , 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 Master Control 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

Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans

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Category Development QA

Astellas is committed to equality of opportunity in all aspects of employment.

EOE including Disability/Protected Veterans