Provide leadership for quality system compliance for all companies facilities. Ensure compliance in all quality activities by implementing a top level Quality System across all sites. Collaborate with Corporate RA and QA Leadership to ensure substantial compliance by aligning quality systems, implementing best practices, sustaining continuous improvement and ensure appropriate resources are in place to support business needs. Support companies business objectives by strategically planning for global growth and possible changes in the business model.
- BA or BS degree in a technical discipline, with a minimum of 10 years’ experience in a regulated industry is required. Masters in Business or Field of study preferred.
- Must be able to lead a multi-discipline team.
- Must be knowledgeable and able to operate under cGMP, cGLP and ISO 13485 regulations.
IDEAL CANDIDATE PROFILE:
- Has the confidence, presence, and ability to inspire, influence, motivate and empower people
- Listens to and values feedback; supports and explains reasoning for decisions
- Respectful of, and actively solicits, team member opinions
- Strong written and oral skills, together with strong organizational and management skills are a must.
- Must have strong problem-solving skills
- Develop short and long-term strategic plans, projecting quality system programs and objectives to support corporate objectives.
- Work with VP, Quality Assurance and Sr. Director Global Regulatory Compliance to assure quality systems are in compliance with ISO 13485, FDA QSR Part 820 and other applicable regulatory standards, including participation in internal and external audits/inspections.
- This position has cross accountability and interactions with Senior Executive Staff, Regulatory Affairs, Quality Assurance, Manufacturing, Engineering, Supply Chain, Research and Development, and Sales and Marketing.
- Collaborate with Corporate Regulatory Affairs team to support or lead product submissions and maintain registrations/certificates, product Technical Files, ISO certificates and other product regulatory certificates.
- Proactively investigate and support opportunities for the continued development of new quality programs/systems.