Manager, QA - CAPA & Deviation
Newark Metro Area, NJ
Must have expert GMP, Quality, and in-depth risk management knowledge in the areas of CAPA and Deviations.
Must have an operational knowledge, including life cycle management experience, of common electronic quality system platforms, preferably EtQ, Veeva and ComplianceWire.
Must complete tasks independently and be confident in making complex decisions in their subject matter area, consulting with supervisor for decisions outside of established processes.
Will interact with and influence across multiple departments and sites.
Shall perform role of global lead for site leadership teams in the areas of Deviations and CAPA.
Must be able to conceptualize broad impact of system related initiatives and recognize quality issues.
Must be a problem solver, actively seeking management guidance on complex issues.
Shall be able to effectively prepare communications to the customer and management in a productive manner with clarity, brevity and accuracy.
Shall provide expert guidance on Quality initiatives and be able to conceptualize broad impact of Quality on sites and/or departments.
Must be familiar with the roles and responsibilities of common GMP functional areas such as Quality, Pharmaceutical Development, Regulatory Affairs and CMC, Technical Operations and Manufacturing.
DUTIES AND RESPONSIBILITIES
Function as the Quality System Owner for the CAPA and Deviation, systems and all associated processes and procedures.
Serve as the subject matter expert for business process and associated electronic systems.
Plan and implement lifecycle changes and system level enhancements through partnership with IT Developers and Business Analysts.
Author and maintain all standards, policies, procedures, work practices and job aides that support the CAPA and Deviation system ensuring all documents and processes comply with applicable regulations, guidance documents and industry best practices.
Develop and conduct user training and manage system access.
Provide input to and execute the strategic roadmap for the electronic CAPA and Deviation modules in eQRMS.
Represent CAPA & Deviation as subject matter expert and process owner in a front-room capacity during all internal and third party audits/inspections.
Create and distribute all metrics, analytics and performance indicators for CAPA and Deviation.
Collaborate with cross-functional system partners and represent the CAPA and Deviation user community in all governance and life-cycle related capacities.
Own and implement a consistent and effective document hierarchy plan for CAPA and Deviation including local and global elements.
Benchmarks through industry associations, system vendors etc. to ensure business processes and systems are consistent with industry best practices.
EDUCATION AND EXPERIENCE
Relevant college or university degree in a scientific and/or clinical area of study preferred.
Minimum 5 years relevant work experience with a minimum of 2 of those years in a leadership capacity
Equivalent combination of education and experience acceptable.