What are the responsibilities and job description for the Quality Systems Manager position at Actalent?
Description:
Develop and implement the Quality Management Systems program, including include Documentation Management, Training, Change Control, Deviations, CAPA, Compliance/Audits, Supplier Quality Management, QA Validation, and Risk Management, that is phase appropriate to support cutting edge technologies for cell and gene therapy. Build, teach, and act as a resource for a team with varying experience levels. Participates in cross-functional teams as an experienced Quality technical resource. Making risk-based, scientifically and/or statistically sound, quality/regulatory compliant decisions. Implementation, roll-out, and maintenance of an electronic Quality Management System in a phase appropriate manner for the company. Ensure compliance with cGMP regulations, guidance, and industry standards. Support hosting client/regulatory inspections, inspection readiness, and reviewing audit reports and responses, as needed. Responsible for the authoring or review and approval of controlled documentation including Policies, Standard Operating Procedures (SOPs), Work Instructions, Quality Records, and other controlled document types. Review of GMP documentation to support the Quality Systems including Document Management, Change Control, Deviations, CAPA, Supplier Management, Audits, Validations, and Risk Assessments. Facilitate the compiling, trending and reporting of key quality system metrics for management, and other technical operations functions. Provide project management leadership for QS department projects/initiatives as needed. Lead continuous improvement of department processes, realizing efficiency gains, and ensuring team continues to meet expanding business needs with lean resources. Partner closely and communicate with other technical operations groups to resolve issues, identify and close gaps, and seek quality compliant outcomes which are efficient and robust. Ability to multitask and to readily shift priorities based on immediate needs. Other duties as assigned.
Skills:
Cell Therapy, quality systems management, CAPA, Change Control, Audit, Management, Manager, Supervisor, Quality assurance
Top Skills Details:
Cell Therapy,quality systems management,CAPA,Change Control,Audit,Management,Manager,Supervisor
Additional Skills & Qualifications:
Bachelor’s Degree in Science-Related Field Preferred at least 5 years (minimum 3 years) of managerial experience in an FDA Regulated environment with direct reports is a must have Experience with electronic quality systems Documentation Management, Training, Change Control, CAPA, Compliance/Audits for inspections. Knowledge of FDA CFR Parts 11, 210, 211, and 1271, ICH Q8/Q9/Q10, EudraLex Vol 4 Part 4: ATMP
Experience Level:
Expert Level
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
- Hiring diverse talent
- Maintaining an inclusive environment through persistent self-reflection
- Building a culture of care, engagement, and recognition with clear outcomes
- Ensuring growth opportunities for our people
Actalent is an equal opportunity employer.
About Actalent
Actalent connects passion with purpose. We help visionary companies advance their engineering and science initiatives through access to specialized experts that drive scale, innovation, and speed to market. With a network of almost 30,000 engineering and sciences consultants and more than 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent serves many of the Fortune 500. An operating company of Allegis Group, the global leader in talent solutions, Actalent launched as a new specialized engineering and sciences services and workforce solutions brand in 2021.
Salary : $145,000 - $160,000
