Quality Systems Manager
Employment Type: Full-Time
At Microbial Material Services (MMS) a division of Thermo Fisher Scientific we deliver, from process development through commercial supply, the expertise and resources necessary to help clients deliver innovative therapeutics. Placed in the forefront of our leading- and cutting-edge Cell and Gene Therapy business enabling clients to cure genetic, rare, and otherwise untreatable diseases.
How will you make an impact?
We are looking for a self-driven, resourceful Senior Quality Systems Manager with up-to-date knowledge, and demonstrated experience driving and sustaining improvement to the Quality Management System to ensure compliance to all applicable standards and regulations (21 CFR Part 11, 21 CFR §210, 21 CFR §211, 21 CFR §600, 21 CFR §610, Eudralex Volume 4, International Council on Harmonization Quality Guidelines, and Guidance to Industry dockets, as applicable)
What will you do?
* Manages to ensure the QMS processes are updated in compliance with applicable regulations and standards ((21 CFR Part 11, 21 CFR §210, 21 CFR §211, 21 CFR §600, 21 CFR §610, Eudralex Volume 4 and ICH guidelines).
* Manages to strengthen and harmonize key Quality Systems processes across MMS and works with sites in the network to streamline core processes (Management Review, Change Control, Complaint management, Deviation, CAPA).
* Shares audit results and best practices to drive proactive change within all sites.
* Liaises with group-level management functions to ensure Management processes are compliant.
* Monitors reports of non-compliance resulting from customer and regulatory audits to ensure corrective action plans are in place.
* Manages to ensure sites key procedures are in alignment with divisional and corporate quality guidance documents.
* Collaborates with Divisional and Group resources to plan and execute on strategic multi-year IT systems roadmap for MMS sites and work with site staff to ensure successful implementation.
* Drives improvement and harmonization of internal audit program for MMS, including but not limited to ensure that MMS sites have trained and competent internal auditors.
* Manages to ensure review boards for key QMS processes are implemented and fully operational across MMS.
* Standardizes communication plans and notifications for Regulatory inspections & audits are communicated upon notification, daily status updates are provided, through final closure of audit.
* Manages to ensure that inter-site agreements are created and maintained and that legal manufacturing ownership is properly defined for MMS sites, internal CMO and customers.
* Manages to ensure that training resources are available for MMS site QA personnel and personnel are trained to applicable regulations.
* Ensures information impacting QMS processes is cascaded appropriately throughout organization.
* Ensures Management is informed in a timely manner of changes / trends in the Quality Management System regulations and standards impacting MMS.
* Assists with internal and external audit support (i.e. travel or virtual).
How will you get here?
* BA/BS required in Life Sciences, IT related discipline or equivalent experience with 6-7+ years of appropriate work experience preferred. Less experience 5+ required with a Master's degree.
* Minimally7+ years' experience with Quality Systems Management. Multi-site quality systems management, preferred.
* Experience in industries regulated in-part by, 21 CFR Part 11, 21 CFR §210, 21 CFR §211, 21 CFR §600, 21 CFR §610, Eudralex Volume 4, International Council on Harmonization Quality Guidelines, and Guidance to Industry dockets, as applicable.
Knowledge, Skills, Abilities
* Excellent organizational skills and attention to detail and accuracy
* Previous management-level experience required - experienced in managing through others in a matrixed organization
* Experience supporting health authority inspections a plus
* Experience successfully coordinating and navigating complex issues with internal and external stakeholders
* Proven ability to successfully coordinate new quality initiatives while managing daily responsibilities