Manager, External Quality

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

·       Demonstrated data driven decision making ability

·       Organizational and operational agility, able to operate at all levels of the organization and able to shift priorities successfully

·       Good computer skills, including proficiency with business and technical software (Word, Access, Excel, Powerpoint)

·       An understanding of the pharmaceutical industry and its unique business and social responsibilities

·       Excellent facilitation and presentation skills

·       Ability to plan, organize, and prioritize

·       Excellent technical and compliance-based writing skills

·       Ability to work with clients of diverse incumbent skill base

·       Ability to manage projects involving multiple functional groups without direct reporting authority

·       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

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Organizational Relationship/Scope:

• Reports to Director, External Quality Operations

Working Conditions:

• Remote, office environment that includes 20% or more travel domestically and internationally.

Statements below needed in every posting:

Keenova offers employees a Total Rewards package which includes competitive pay and benefits.  To learn more about our Total Rewards benefits please visit: Keenova Careers | Serve and Grow with Purpose | Keenova

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications.  Management reserves the right to change or modify such duties as required.

Pay Transparency Statement (if needed) : refer to pay transparency guide

• The expected base pay range for this position is €80,000e – €108,000. Please note that base pay offered may vary depending on factors including job-related knowledge, skills, and experience.
• This position is eligible for a bonus in accordance with the terms of the applicable program. Bonuses are awarded at the Company’s discretion.

At Keenova, we believe that no one should be alone in their pursuit of better health. This purpose drives us as we pair quality therapeutics with human support—showing up in big moments and small to help patients find comfort and confidence.

We bring deep expertise and resolve to every therapeutic area we serve, including immunology, urology, men’s health, orthopedics, critical care, and pediatric endocrinology. We work with patients, care partners, and physicians to help them navigate healthcare system complexity and access therapies that make a meaningful difference.

We are Keenova—keen to solve, keen to serve. Learn more at www.keenova.com.