Senior Director Global Analytical Services & Site Director
NAMSA pioneered the industry, NAMSA was the first independent company in the world to focus solely on medical device materials for safety. NAMSA started testing medical devices before the U.S. Food and Drug Administration started regulating such products in 1976.
We are shaping the industry. NAMSA has been a key contributor to the development of the test methods that govern our industry.
We have become the industry’s premier provider. We provide support for clients during every step of the product development lifecycle and beyond.
Come and work for an organization whose:
- Mission is to make a scientific contribution to every medical device in the world.
- Culture is passionately committed to the partnership between one another and our clients to improve and save lives through a respectful, trusting, and collaborative environment.
- Values have stood the test of time.
- Above all else, conduct ourselves with integrity
Job Description:
- Responsible for planning, directing and coordinating the technical and operational activities of global analytical services
- Provide technical and operational support to sales and marketing. Support MRO by collaborating with others.
- Ensures the timely delivery of testing services and ensures laboratories operate in compliance with applicable quality and regulatory requirements.
- Oversees a safe and healthy work environment at the assigned NAMSA site and helps to maintain general site support operations
- Ensures that all business line activities are timely, meet/adhere to, supports and implements all corporate policies including that Standard Operating Procedures (SOP) are followed, up-to-date and GLP compliant.
- Implements and manages, with the Quality Manager, the compliance with applicable requirements of ISO 13485 and 17025, FDA, ASCA, DEA, OSHA and local health agencies.
- Represents the organization to industry groups, key customers, representatives of government and regulatory agencies, and the general public. Interacts with government representatives and customers when site visits are conducted.
- Strong, influential communicator (verbal and written) with peers and senior management.
- Responsible for staffing, training, developing, motivating and mentoring all levels of Associates to improve technical and management related skills.
- Strategically partners with senior management and peers to develop and establish continuous productivity improvement programs, infrastructure for growth and capacity, manage cost-of-goods-sold (COGS), gross margins and profit-from-operations (PFO).
- Directs financial objectives, department budgets and annual sales goals for department. Analyzes variances and implements corrective strategies.
- Reacts and responds to customer feedback and complaints.
- Fulfills the responsibilities of Test Facility Management during the conduct of regulated studies according to all applicable regulations and facility SOPs when assigned site is the testing facility or the test site.
- Other duties as assigned
Qualifications & Technical Competencies:
- Minimum Bachelor’s degree in a scientific discipline. Advanced scientific or business degree (MBA) preferred.
- 15 years related experience including progression in management accountabilities; executive leadership preferred.
- Profit & loss experience required.
- Experience planning and managing integration efforts.
- Fluency in English and local language, if different, required.
- Working knowledge of laboratory disciplines, quality assurance and laboratory operations.
- Familiarity with GLP
Working Conditions:
- Physical activities include sitting for long time periods and occasionally standing and walking.
- Extensive use of computer keyboard and mouse.
- Travels up to 20-30%.