Contact: Terry McCarthy
(949) 716-3524
tmccarthy@prodigysearchgroup.com

Position: Senior Manager, Laboratory Operations
Industry: Medical Device
Location: Texas – will relocate

DESCRIPTION

Our client has made significant contributions to surgery for more than 60 years from creating the first
sutures, to revolutionizing surgery with minimally invasive procedures. Their continuing dedication to
Shape the Future of Surgery is built on their commitment to help address the world's most pressing
health care issues and improve and save more lives.

The Senior Manager, Laboratory Operations is responsible for leading and coordinating the activities of
the laboratory professional staff, scientists, and technicians engaged in testing medical device products
to ensure compliance with quality standards and production schedules.

At this level, this position has a great degree of impact on business results and responsibility for leading
a diverse group of Associates.

RESPONSIBILITIES
The Senior QC Lab Manager will plan, coordinate and direct laboratory actions to ensure continuous
flow of testing, while meeting safety, quality, delivery and cost requirements. In addition will:

Administer available resources to achieve a reliable, efficient and productive operation and will
utilize a thorough familiarity with relevant regulations for the manufacture and testing of medical
devices (e.g., ISO 13485, ISO14001 & OSHAS18001 and EC Medical Device Directive).

Evaluate new and existing documentation and test methods. Oversight for validating,
transferring, and recommending changes to test methods as required.

Review and approve laboratory investigations, consulting with others as needed.

Develop and implement systematic and effective processes to investigate and resolve
laboratory performance issues.

Responsible for continuous improvement for laboratory processes and increase product quality
and delivery while reducing operating costs.

Mentors, coaches, trains and develops the laboratory staff and evaluates performance,
formalizes development plans, and provides opportunities for growth.

Participate in planning and implementing changes in laboratory methods, instruments and
equipment, space allocations, workforce utilization, testing schedules, lines and other factors
required to maintain or improve compliance with quality standards of existing products.

Manage the development and implementation of metrics and systems to measure and guide
improvements to product and system quality and customer satisfaction.

Prepare, manage, and administer budget. Approves OT, timecards, etc.

Support internal and external audits as necessary. Ensures timely resolution of any audit
observations.

The San Angelo Plant is a 24/7 operation; weekends and holidays are included in the work
schedule

QUALIFICATIONS

Education:

Bachelor’s degree in science or related subject area is required. An advance degree (i.e., MBA)
in Business, Science or Engineering or related degree preferred

Minimum 8-10 years related experience in laboratory operations in the pharmaceutical or
medical device industries

EXPERIENCE AND SKILLS

Required:

Strong business acumen (i.e., financial), experience in managing budgets, understanding
planning and forecasts

Minimum 3 to 5 years’ experience managing professional and technical level associates.

The ability to effectively partner and deliver results in a matrixed environment

Strong project management skills, confirmed organization, coordination and action tracking
skills

Developing a team and building positive, proactive quality culture

Demonstrated relationship building skills, working collaboratively with cross functional partners.

Excellent technical and analytical skills with familiarity with basic industrial microbiological
techniques

Experience with GMP, EHS, compliance and regulatory standards

Ability to organize and follow up on multiple priorities.

Experience with management of investigation/ CAPA process and continuous improvement

Preferred:

Experience with pharmaceuticals or combination products highly desirable

Knowledge and experience with chemical and physical testing equipment, such as GC, HPLC,
UPLC, AA, Instron, viscosity, FTIR, UV, Conductivity, pH meters, TOC and the like.

Process excellence statistical and analytical problem-solving skills. Certified Green Belt or Black
Belt (preferred)

Knowledge of lean laboratory processes

Excellent oral and written communication skills.