Job Title
Manager, External Quality
Requisition
JR000016095 Manager, External Quality (Open)
Location
College Park, Dublin
Additional Locations
Job Description Summary
Position Summary: The position provides complete oversight as Quality Manager for assigned contract manufacturing organizations (CMO) and assigned product lines. Oversight includes complete signature authority, with responsibility for escalating high risk issues to management. The position acts as a decision maker regarding compliance issues and leads projects and issue resolutions that cross site or divisional lines. The position is responsible for building, maintaining and managing the relationship with their counterparts at the CMO and cross-functional MNK team members. The position is responsible for appropriate escalation to Director level management and above. The incumbent will coordinate compliance activities / projects with key CMO and Keenova groups. The main result of the incumbent will be to ensure compliance with cGMP, regulatory and internal requirements domestically and internationally regarding the manufacturing, testing and distributing of products.
Job Description
Key Responsibilities :
Provide oversight for assigned CMOs and/or product lines and Quality staff, including but not limited to: Change management
Investigations (process, complaint, and laboratory)
Product release
Annual Product Review
Management Review (as applicable)
Master documents (batch records, methods, labels, etc…)
Validation protocols and reports
Stability data review / stability coordination
CAPA
Provide quality, compliance and business strategy for major initiatives
Assign resources to projects and organize work / provide guidance to direct reports
Support CMO audits and supports audits as part of the audit team as necessary
Identify, develop and execute project plans and timelines to achieve desired results
Champion continuous improvement efforts for projects identified at the CMOs or within Keenova
Participate actively on cross-functional support and process improvement teams
Seek to identify and execute safety improvements and waste minimization opportunities
Create, approve, and implement quality system procedures associated with the product realization process as well as procedures associated with CMO management and oversight
Plan, execute and follow up on CMO site visits due to identified issues, validation/transfer activity or as routine periodic visits
Ensure material review board (MRB) and field alert report (FAR) decisions are appropriately made and executed, including follow up investigation
Support CMOs and Keenova with FDA and other regulatory body investigations and inquiries as needed
Design and monitor Key Performance Indicators (KPI) and develop and monitor staff goals accordingly
Provide leadership to QA staff, as assigned; including goal setting, work assignment/prioritization, issue resolution, and personnel development
Evaluate and provide QA recommendations on all products, systems and issues that are/may be affected by regulatory or cGMP requirements.
Qualifications:
Education
· Minimum BS in Chemistry, Chemical Engineering , related science or equivalent combination of Education, Experience and Competencies
· Minimum 5-7 years’ experience in a quality engineer or equivalent role
Experience
· Extensive experience in cGMP systems, pharmaceutical manufacturing and testing, experience must include role(s) in a manufacturing setting
· Preferred experience including, but not limited to the following:
o Application of cGMP to manufacturing and testing
o Product release and investigations
o Change Management and CAPA
o FDA inspections / Regulatory Affairs
o Validation
o Statistical techniques
Preferred Skills
· Self-motivated and self-managing. Able to identify, execute and prioritize work tasks/projects with an awareness of escalation responsibility as needed.
· Critical problem-solving skills
·…