Manager-Quality Management Systems - United States
Want to know company name or location? Company managed [?]
Reporting To: Director, Quality
Summary & Scope of Position: The Manager, Quality Management Systems (QMS), will be responsible for the improvement, design, development, implementation and maintenance of the GxP QMS processes. This includes, but is not limited to, Change Control, Deviation and other Non-conformances, CAPA, Equipment/Instrument associated systems, Supplier Management, and Risk Management. The role is focused on improving and maintaining the business processes and will include being the Quality Lead on the implementation of IT solutions/systems. The Manager will address gaps associated with the current processes as part of preparing for current and future clinical operations of our products.
- Lead the development, continuous improvement and implementation of Quality Systems
- Improve Change Control, Supplier Management and CAPA processes
- Improve and establish standard operating procedures for efficient and compliant management of GxP QMS processes
- Establish and track quality metrics for QMS processes and present improvement opportunities at Management Review meetings
- Implement risk management based approaches
- Conduct domestic and international Quality System audits (e.g., CMO Qualification, Assessement, For Cause, and/or Periodic audits) to ensure that the sites operate in compliance with EU/FDA/ICH and other regulatory bodies as may be required and remain GMP inspection ready at all times.
- Interface with FDA / EU and other regulatory agencies, customers and consultants
- Represent QA on cross-functional teams to complete projects, address quality issues and implement quality system improvements
- Identify compliance gaps and leading focused teams to resolve compliance issues. Provide written compliance assessments to management on request, and interpreting global regulations and applying them to a multi-product, multi-modality environment.
- Develop, or review, Operating Procedures (SOPs) required for supporting system change/enhancement to ensure compliance with Good Manufacturing Practices (GMPs) requirements
- Establish and maintain policies and procedures to ensure compliance with local, state and federal environmental regulations and standards including compliance with all Food & Drug Administration (FDA) and all other applicable global regulatory requirements
- Establish and oversee internal quality systems and policies throughout the company.
- Responsible for the co-ordination and preparation of activities related to regulatory agency inspections at company facilities, CMO’s, vendors and investigator study sites.
- Prepare GXP quality metrics; analyze data relating to process validations, process controls, and continuous process improvement efforts; coordinate the necessary quality adjustments.
- Provides QA support to IT projects as needed.
- BA/BS degree in scientific or engineering discipline
- Accredited quality auditor is desirable
- 6+ years of biopharmaceutical industry experience
- Direct experience with managing key Quality Management System processes (e.g., Change Management, Supplier Management, Deviations/CAPA, Management Review)
- In-depth understanding of current global regulatory expectations
- Demonstrated ability to collaborate and influence across organization to gain support and commitment for team goals; effective management of groups of professionals to achieve desired results
- Strong professional interpersonal and communications skills, both verbal and written to provide clear direction for the business, vendors, internal stakeholders
- Ability to meet deadlines and multi-task efficiently
- Comfortable in a fast-paced environment with minimal direction and changing priorities
- Experience identifying changes, driving improvements and streamlining processes
- Proficient with the Microsoft Office Suite, Word, Excel, PowerPoint and Project
- Experience in preparing for and participating in regulatory inspections to ensure successful outcomes
We are at the forefront of discovery, development and commercialization of breakthrough immunotherapies, alone or in combination that make transformative advances in the treatment of challenging diseases. We provide a workplace where employees excel, thrive and deliver value to patients, their families and our partners.