Director, Quality Control

Position Summary:

Director, Quality Control is responsible for managing the Quality Control Team. This position provides leadership, direction, and coordinates all Quality Control Laboratory activities in accordance with the Group’s procedures, policies, goals, and objectives. As the Group continues to grow, the Director of Quality Control will build and lead a highly performing team of quality professionals to meet all current and future needs of the Group and its clients. The ideal candidate should be able to communicate at all levels of the organization and be highly motivated and self-driven.

Essential Duties & Responsibilities:

Specific responsibilities include, but are not limited to:

• Assist Vice President of Global Quality in the development and implementation of the Quality Control Laboratory and site-specific Quality Management Systems (QMS) to meet cGMP requirements including SOPs, client-specific procedures, and safety training programs.
• Client Facing role working with clients to define Scope of Work and stability study models.
• Oversee the Quality Control Laboratory in regard to human resources including interviewing and selection, organizational development, mentoring, coaching, counseling, and employee discipline, as required.
• Manage Quality Control Department laboratory personnel to include:
  • Managing and prioritizing workloads and projects to ensure effective and efficient completion of Quality Department objectives.
  • Developing and delivering Quality Department personnel performance evaluations.
  • Maintain appropriate work/life balance for all members of the department.
  • Approving Time Off Requests (PTO).
  • Actively engaging in laboratory Quality and Analytical activities.
  • Collaboratively working with Senior Management to establish and monitor key performance indicators (KPIs) for Quality personnel.
  • Ensuring the Quality Department maintains a perpetual inspection-ready state.
  • Ensure all Group employees and on-site service vendors are trained in (as applicable) cGMP, Group SOPs, policies, Client-specific procedures, and safety programs.
• Oversee and direct the implementation and operation of the Quality Control laboratory activities providing bulk sampling, stability assessments, and material evaluations.
• Ensure that all Client products are evaluated in compliance with QMS, Quality Technical Agreements, cGMP, and applicable laws and regulations.
• Responsible for oversight and management Quality Control Laboratory functions such as Laboratory Investigation upon generation of out of specification results; initiate, manage and/or assist in investigation of process deviation or non-conformance, and lead internal audits of Quality Control Laboratory operations.
• Responsible for management of laboratory equipment including commissioning, qualification, calibration, and routine preventative maintenance.
• Assure metrics, goals, and priorities are implemented within the Quality Control department.
• Participate in and provide support for on-site regulatory for laboratory operations including Client and third-party audits of this area.
• Maintain a working knowledge of applicable laws, regulations, and cGMP/GLP requirements.
• Direct initiatives that accomplish continuous improvement, cost effectiveness, new capabilities, and enhanced efficiencies of laboratory operations while maintaining compliance of processes and procedures.
• Communicate to the Vice President of Quality any critical cGMP and/or non-compliance issues in a timely manner.
• Be a contributing member of the leadership team and engage in business decision making from a Quality perspective.
• Facilitate interactions between QC Laboratory, Quality Assurance, Operations, and Business Development teams in order to help set and meet Clients’ quality requirements while maintaining compliance.
• Other duties and responsibilities as assigned.

Qualifications:

• Excellent leadership skills including the ability to lead projects with a broad scope, cross functional nature and ability to impact outside department while promoting teamwork between departments.
• Embraces change and is dedicated to continuous improvement. Consistently searching for more efficient and effective ways to improve processes and procedures.
• Excellent communication skills with all levels of the organization and ability to develop rapport with other functional leaders within the Group to make decisions.
• Drives results through team leadership. This would include working with the team/individual to define specific goals and progress measuring tools.
• Strong problem solving, solutions orientation and presentation skills.

Education and/or Experience:

• BS or BA degree in life sciences, physical sciences, engineering, or related discipline. 8 years or more of quality control laboratory experience in pharmaceutical, medical device, or other related industries or an equivalent combination of education and experience.
• In-depth knowledge of regulatory requirements for laboratory and pharmaceutical manufacturing operations including Title 21 CFR § 211 requirements, ICH guidelines, FDA cGMP/GLP regulations, and on EU Regulations.
• Management experience in operation of Quality Control or Analytical Laboratories is preferred.
• Proven ability to work cross-functionally to achieve business outcomes.
• Experience in auditing/inspecting, data and document review, internal and external inspection.
• Sufficient knowledge of general pharmaceutical lab methods, techniques, and instrumentation to be able provide oversight and direction to laboratory personnel performing typical pharmaceutical stability analyses.
• Capable of working on multiple projects simultaneously. Must be well organized along with being detail and multi-task oriented. Ability to meet aggressive timelines.
• Good interpersonal/teamwork skills. Must possess and demonstrate motivational and leadership qualities.
• Effective communication skills (verbal and written form) to include experience in technical writing, including requirements gathering, is required.

The pay will be commensurate with the experience, skills, and qualifications that the candidate brings to the position.

Job Type: Full-time

Pay: $100,000.00 - $130,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Ability to Relocate:

• Edinburgh, IN 46124: Relocate before starting work (Required)

Work Location: In person