Vice President, Global Quality and Regulatory Compliance

NAMSA pioneered the industry and 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 with the:

Vision to inspire innovative MedTech solutions that advance global healthcare, improve patient lives and accelerate Client success and the

Mission to deliver best-in-class global MedTech development solutions through our people, expertise and technology by adhering to our core

Values:

• Act with integrity in everything we do.
• Provide best-in-class customer experiences.
• Develop superior talent and deliver expertise.
• Respond with agility and provide timely results.
• Embrace collaboration, diverse perspectives and ideas.

Job Description:

• Sets the strategic philosophy and direction for NAMSA’s global quality and regulatory compliance systems applicable to all functions and entities.
• Owns the quality direction including the research, monitoring and communication of current and changing regulations including applicable laws and guidelines.(e.g., US and ex-US GxPs, ISO requirements).
• Develops and maintains external relationships with key opinion leaders, medical directors and regulatory officials.
• Designs and implements systems and controls to ensure consistency and compliance with applicable regulatory requirements, across the global NAMSA network.
• Selects, trains, and supervises staff to perform quality engineering, quality assurance, quality systems and quality/regulatory compliance functions consistent with strategic plans for ongoing implementation of the NAMSA Quality Policy.
• Oversees the Corporate Quality System ensuring compliance with all national and international standards and regulations, including but not limited to US FDA, CFDA and applicable ISO standards for the Company.
• Develops and directs the internal quality system support functions for NAMSA, including Document Control, Archives/Records, Training, CAPA, Complaints, Management Review, Business Software Validations, Internal/External compliance Audits, Supplier Approval and Supplier Audits, Quality Engineering, and GxP Quality Data Audit/Review/Approval.
• Works cooperatively with NAMSA Leaders to implement programs to improve overall quality and increase regulatory compliance. Assures test validation and audits accurately assesses ongoing performance and detects quality problems. Promptly notify management of significant quality system or technical problems.
• Directs and accomplishes financial objectives for the Quality organization by forecasting requirements; preparing an annual budget; scheduling expenditures; analyzing variances; initiating corrective actions; effective utilization of resources, equipment (engineering) and space.
• Acts as the primary interface with the US FDA and other regulatory authorities globally for compliance inspections.

• Develops and maintains a three-year staffing and space requirement plan. •

• Advises and assists clients regarding quality and regulatory concerns.

Qualifications & Technical Competencies:

• Requires a Bachelor’s degree in life sciences, pharmacy, engineering or a related field
• Requires minimum 15 years in Quality Assurance and Regulatory Affairs with at least 5 years in a senior leadership role within the medical device, biotech or pharmaceutical industry
• Deep knowledge of global regulatory requirements
• Proven ability to lead cross-functional teams, influence stakeholders and drive strategic initiatives
• Strong analytical, problem-solving, and communication skills, adept at managing complexity in a global environment
• P&L experience required
• Fluency in English and local language, if different, required.
• Maintains professional competency in Quality Assurance and the biomedical industry in general.
• Must have familiarity with a broad base of scientific applications sufficient to support understanding and sound risk assessments of NAMSA’s products and processes.

Working Conditions:

• Physical activities include walking, sitting and standing for prolonged periods.
• Extensive use of computer keyboard and mouse.
• Travels approximately 30% - 40% of the time.

Pay Range Minimum:

$171,500.00

Pay Range Target:

$200,000.00

Pay Frequency:

Annual

Please Note: Individual base pay depends on various factors, in addition to primary work location, such as complexity and responsibility of role, job duties/requirements, and relevant experience and skills.

Fair Chance Employment Statement:
At NAMSA, we are committed to providing equal employment opportunities to all qualified applicants, including those with arrest or conviction records. In accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act, we will consider qualified applicants with a criminal history.

Please note that NAMSA conducts a review of criminal history after the interview process and offer acceptance. This review is conducted to ensure that there is no direct, adverse, or negative relationship between the criminal history and the material job duties of the specific position. The following is a list of material job duties for this position:

• May operate equipment
• Records data timely and accurately
• May analyze and interpret data
• Conducts studies on medical devices that have an impact on human life

A criminal history that directly impacts the ability to perform these duties may result in the withdrawal of a conditional offer of employment. We believe in fair chance hiring and are committed to evaluating each applicant on a case-by-case basis.