What are the responsibilities and job description for the Quality Systems Manager position at Systemsally?
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Job Summary
The Manager, Quality Systems provides quality assurance leadership and oversight for regulated manufacturing processes, including pharmaceutical products, medical devices, cosmetics, biologics, and combination products. This role ensures that quality systems support business objectives and comply with applicable regulatory requirements. The position translates strategic quality objectives into executable plans and ensures end-to-end compliance across product, process, and system activities—from raw material inspection through final product release and distribution.
This role supports and oversees key quality system functions, which may include document control, device quality assurance, labeling, validation, training, quality data and metrics, compendia management, and corrective and preventive actions (CAPA).
Key Responsibilities
- Ensure compliance with applicable quality and regulatory requirements for drug, biologic, cosmetic, device, and combination products.
- Lead cross-functional project teams in the planning, preparation, review, and approval of quality documentation.
- Implement, maintain, and continuously improve the effectiveness of quality systems in alignment with regulatory requirements and internal policies, processes, and procedures.
- Design and optimize quality system processes to ensure regulatory compliance, operational efficiency, and inspection readiness.
- Prepare and present quality system data and documentation during internal and external regulatory inspections and audits (e.g., FDA, EMA, Anvisa).
- Oversee quality system activities that interface with Research & Development, Manufacturing, Supply Chain, Program Management, Commercial, Medical, Pharmacovigilance, and Regulatory Affairs functions.
- Coordinate quality system elements, including training, continuous improvement initiatives, and tactical support across sites and functional areas.
- Support new product introductions and lifecycle management activities, including design changes for medical devices and combination products.
- Collaborate with internal and external stakeholders to establish and maintain best practices in quality systems and procedures.
- Conduct compliance assessments to identify gaps, mitigate risks, and implement corrective and preventive actions.
- Oversee the development, implementation, and maintenance of training and education programs related to quality assurance and quality systems.
Qualifications
- Bachelor’s degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering, or a related scientific or technical discipline.
- Minimum of 8 years of experience in quality assurance, quality oversight, or a related regulated environment.
- Demonstrated experience leading technical professionals and cross-functional teams.
- Broad technical knowledge across quality systems, regulatory compliance, process sciences, and manufacturing operations.
- Working knowledge of products, processes, equipment, and facilities associated with pharmaceutical, biologic, and/or medical device manufacturing.
- Strong understanding of GMP requirements and quality system regulations applicable to pharmaceuticals, biologics, and medical devices.
- Proven ability to work both independently and collaboratively in a team environment.
- Strong written and verbal communication skills, with the ability to communicate effectively at all organizational levels.
- Demonstrated ability to lead medium to large, complex projects and deliver results aligned with strategic objectives.
Pay: $50.00 - $75.00 per hour
Work Location: In person
Salary : $50 - $75