Associate Director Quality
Merck · United States, Pennsylvania, West Point
Job Description
Our Quality organization ensures every single material inside our products is manufactured, processed, tested, packaged, stored, and distributed in alignment with our incredibly high standards of quality while meeting all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers, and suppliers, we create an interdependent global manufacturing network committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.
The Associate Director within Quality is responsible for providing quality direction and oversight to a Drug Substance capital project according to our quality systems, including Training, Documentation, Change Control, Inspection Management, Quality Management System, and Risk Management to maintain compliance with regulatory requirements.
The individual is an advocate and leader for the development, execution, and deployment of the site and end-to-end priorities. The Associate Director drives quality improvement activities and ensures alignment across the organization in the execution of their assigned areas. The Associate Director is responsible for quality oversight of the Capital Project and the associated Quality Systems.
The qualified candidate ensures compliance with divisional, company, and site standards and procedures.
This is an individual contributor role and partners with the operations and technical operations leaders to ensure that the facility will be designed and qualified in alignment with approved processes and comply with all applicable regulatory and internal requirements.
The selected candidate will play an active role in regulatory inspections, interacting directly with regulatory inspectors when the facility moves to pre-approval inspections. The qualified candidate must demonstrate strong analytical and scientific acumen to assist with the troubleshooting of processes and systems, as well as excellent leadership capabilities. These include cross-functional collaboration, written and verbal communication skills, structured problem solving skills, disciplined decision-making, and talent management experience.
Essential Functions and Responsibilities (Includes, but are not limited to)
The Associate Director, Quality Lead, is responsible for:
1.) Executing quality system functions relating to GMP compliance, and coordinating and directing multi-department teams to support ongoing maintenance and enhancements of the quality system(s)
2.) Ensuring personnel operate within established policies and procedures of our company and in compliance with cGMPs and all applicable government regulations.
3.) Ensuring that all team members operate safely and comply with established safety and environmental policies and procedures (Corporate, Site, and Governmental)
4.) Serving on local and site governance committees, Technical/Operations Reviews, and regulatory forums, as well as participating and driving strategic initiatives.
5.) Acquiring and maintaining technical process knowledge to support critical thinking and decision making.
6.) Reviewing and approving compliance documents such as deviations, corrective / preventive actions, commitments, and change requests.
7.) Primary Quality lead for Capital Project support in design, qualification and approval phase.
Minimum Education Requirements and Experience:
- Bachelor's Degree in Science, Engineering, or another technical field with eight (8) years’ experience in a functional area, such as Operations, Quality, Technical Operations, Technology, Engineering, Maintenance, and/or Supply Chain OR
- Master’s degree in Science, Engineering, or another technical field with six (6) years’ experience in a functional area, such as Operations, Quality, Technical Operations, Technology, Engineering, Maintenance, and/or Supply Chain
Required Experience and Skills:
- Minimum two (2) concurrent years’ experience managing direct reports.
- Strong understanding of CGMPs, FDA, and EMEA regulatory standards and strong compliance mindset.
- Proven analytical aptitude, critical thinking skills, and ability to apply key concepts.
Preferred Experience and Skills:
- Compliance - Responsible for creating and sustaining a culture that ensures that compliance (Safety, Environment, cGMP, etc.) are imperatives for the business. Responsible for establishing a Right First-Time culture by reducing waste and constantly driving continuous improvement. Responsible for authoring, reviewing and approving compliance documents. Has experience and proven ability to achieve compliance goals, through a risk-based approach. Has a deep understanding of GMP and EHS compliance and compliance risk.
- Working Across Boundaries – Must possess excellent interpersonal, communication, collaboration, and negotiation skills to work outside boundaries as a norm.
- Business Outcomes /Drive Results – Ability to use deep knowledge and expertise in production operations to drive results and business outcomes.
- Demonstrated experience interacting site, divisional or regulatory auditors.
- Demonstrated ability to create an engaged and inclusive workforce
- Demonstrated knowledge of high performing organization tools and methodology, including lean processing and Inclusion. Our Company Production System (MPS) experience - LSS Green Belt certification or equivalent experience.
- Demonstrated success with Talent Management including leading, coaching and mentoring.
- Proven ability to manage multiple projects simultaneously.
- Applies knowledge of internal/external business challenges to improve products, processes, or
- services.
- Solves complex problems; takes a new perspective using existing solutions.
- Works independently, receives minimal guidance.
- Demonstrated self-starter with capability to develop innovative solutions to challenges.
- Aseptic/sterile processing experience.
- Quality or Operations experience in Pharmaceutical, Biologics, Vaccines, or Therapeutic Protein manufacturing.
Required Skills:
Aseptic Processing, Aseptic Processing, Audit Management, Business Alignment, Business Decisions, cGMP Training, Change Controls, Coaching, Compliance Activities, Compliance Reporting, Critical Thinking, Customer-Focused, Detail-Oriented, Driving Continuous Improvement, Ethical Standards, Government Regulation, Logical Thinking, Operational Compliance, Operational Quality, Policy Compliance, Procedure Adherence, Quality Control Documentation, Quality Management Systems (QMS), Quality Metrics, Quality Risk Management {+ 9 more}
Preferred Skills:
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