Quality Operations Manager at Mallinckrodt Public Limited Company in Hampton, NJ

Job Description

Summary

The position provides complete oversight as Quality Manager for assigned contract manufacturing organizations (CMO) and assigned product lines. The 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 Mallinckrodt 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.

Essential Functions

• 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…)
• Design History File (as applicable)
• Device History Record (as applicable)
• 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 Mallinckrodt
• 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), Biological Product Deviation Reports (BPDR) and field alert report (FAR) decisions are appropriately made and executed, including follow up investigation
• Support CMOs and Mallinckrodt 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.

Minimum Requirements

Education / Experience / Skills:

Education:

• Minimum BS in Chemistry, Chemical Engineering , related science or equivalent combination of Education, Experience and Competencies
• Advanced degree preferred
• Certification as Quality Engineer or Six Sigma Black Belt strongly preferred
• Certification as a Quality Auditor or Quality Manager helpful

Experience:

• Minimum 5 years’ experience in a quality engineer or equivalent role
• 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:
• Application of cGMP to manufacturing and testing
• Product release and investigations
• Change Management and CAPA
• FDA inspections / Regulatory Affairs
• Validation
• Statistical techniques

Other Skills/Competencies:

• Strong communication skills
• Demonstrated leadership abilities
• Demonstrated commitment to excellent customer service
• Conflict resolution skills
• Requires mature judgment in problem solving situations.
• Requires negotiation skills to effectively influence others
• Ability to identify and drive continuous quality improvement
• Must have valid Passport for respective country of residence

Organizational Relationship/Scope:

• Reports to Sr. Director, External Quality Operations
• Works under self-direction toward predetermined long-range goals and objectives
• Assignments and projects are self-initiated and self-monitored
• Determines and pursues courses of action necessary to obtain desired results
• Requires minimal direction
• Routine contacts with external customers, multiple site and corporate departments on significant matters requiring coordination between organizations to ensure continuous improvement and implementation of identified projects / system

Working Conditions:

• Office environment and production environment, as necessary to accomplish the objectives of the role as it relates to process knowledge and process improvements.
• Travel required (Up to 50% average with higher peaks possible)—both domestic and international