We are in search of a Director, Compliance and Regulatory Affairs who possesses the talents, skills and knowledge to assist the Vice President, Quality and Regulatory Affairs with quality/regulatory oversight of our blood and umbilical cord bank, cellular therapy services, laboratory, life science research and clinical trials. Successful candidates will contribute to our respectful, constructive and collaborative style, which is guided by applicable rules, laws, regulations and standards and the objectives of the company.
With its great weather, vibrant academic life science community, miles of sandy beaches and major attractions, San Diego is known worldwide as a great place for residents to collaborate, engage and relax year-round.
Qualified candidates must have a master’s degree in business, healthcare or related field/discipline from an accredited college or university and possess ten years of progressively responsible and directly related experience, including at least five years in a management position, providing direction and oversight of regulatory and operational compliance. Participation in federal and state site inspections, experience with good manufacturing practice (GMP) requirements, application of quality assurance principles, and health care compliance required. Additional experience in clinical laboratory and cellular therapy services, umbilical cord banking, molecular testing and/or clinical research is preferred.
Health Care Compliance Certification Board certification or equivalent required upon hire or commitment to obtain within one year of hire.
Manage the day-to-day operations of the Quality Assurance and Compliance department.
Provide reports to the Vice President, Quality and Regulatory Affairs, Chief Compliance/Privacy Officer and the Operational Compliance Committee on a regular basis, and as directed or requested, to keep Executive Management and Board members informed of the operation and progress of compliance efforts.
Conduct regulatory research and provide guidance and interpretation of new laws, rules, regulations and standards.
Implement effective compliance activities through an efficient use of resources and a focus on continuous performance improvement initiatives designed to maximize compliance.
Embody and promote an overall culture of compliance that encourages ethical conduct and a commitment to compliance with laws, rules, regulations and standards.
Work effectively with other San Diego Blood Bank leaders to facilitate open communication and operational excellence.
San Diego Blood Bank is an Equal Opportunity Employer. EEO/Minority/Female/Disability/Vets
To apply to this position click on the link below.
Traditional blood banking is at an exciting inflection point, needing to respond to a number of local and national market changes. As a leader in the blood industry, San Diego Blood Bank’s strategy is to anticipate trends and proactively define innovative strategies that leverage and extend core business activities that make an even greater impact on our community’s health. San Diego Blood Bank provides high quality blood and biological products on a local, regional, national and international scale while simultaneously integrating into U.S. and worldwide scientific and clinical communities to actively drive the future of healthcare through research.