Lab Operations Manager

Manager, Lab Operations is responsible for building and maintaining the Quality Control Lab Operations. This position provides leadership, direction, and manages all Quality Control Instrumental and software activities in accordance with the Group’s procedures, policies, goals, and objectives. As the Group continues to grow, the Manager of Lab Operations will build and lead a highly performing team of quality professionals to meet all current and future of the laboratory needs supporting both Sentry and client interests.  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 Quality Control Director 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.
• Oversee the Quality Control Laboratory in regard to instrumentation and software validations. Maintain all systems in working order per GMP requirements.
• Responsible for assisting in the creation of instrumentation SOPs and validation protocols/reports.
• Maintaining a calibration and maintenance schedule for all instrumentation.
• Lead the implementation and validation of the CDS and sample management systems
• Oversee and direct the implementation and operation of the Quality Control laboratory systems.
• 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, Vendors and Business needs in order to help set and meet 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. 5 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.

Location: Columbus, IN

Department: Quality Assurance

Schedule: Full Time, On-Site

Experience: 5Years of Quality Control Laboratory Experience
(Required)

Education: BS or BA in Life Sciences, Physical Sciences, Engineering