Director, Compliance and Regulatory Affairs

JOB SUMMARY

Working under the direction of the Vice President, Quality and Regulatory Affairs, the Director of Compliance and Regulatory Affairs (“Director”) provides oversight and direction for the daily operation of the San Diego Blood Bank (SDBB) Quality Assurance and Compliance (QA) department. The Director is a leader and regulatory subject matter expert, joining enterprise-wide projects to achieve business operation excellence and compliance with all measures relative to state and federal laws and regulations and accreditation standards 

RESPONSIBILITIES 

• Conducts regulatory research and provides guidance and interpretation of new regulations and standards throughout the organization.
• Provides reports to the Vice President, Quality and Regulatory Affairs on a regular basis, and as directed or requested, to keep Executive Management informed on progress of compliance efforts.
• Plans and develops work plans, provides training and reports results of work effort to Vice President, Quality and Regulatory Affairs.
• Responds to alleged violations of laws, rules, regulations, standards, policies and procedures by initiating investigative procedures, including developing and overseeing a system for uniform handling of such violations/nonconformances.
• Implements effective compliance activities through an efficient use of resources and a focus on continuous performance improvement initiatives designed to maximize compliance.
• Embodies and promotes an overall culture of compliance that encourages ethical conduct and a commitment to compliance with laws, regulations and standards.
• Supervises and delegates specific tasks to staff and ensures timely completion.
• Attends and/or co-chairs quality, compliance and change management meetings and ensures meeting documentation is complete and timely.
• Demonstrates high integrity and works effectively with other SDBB leaders to facilitate open communication and operational excellence.
• Fosters team member engagement by establishing clear objectives, and through coaching, counseling and evaluation of performance.
• Performs other related duties as assigned or requested. 

WORKING ENVIRONMENT 

• Normal office environment. 

PHYSICAL REQUIREMENTS

• May be subject to prolonged sitting; reaching horizontally.
• Must be able to work on a computer 4 – 8 hours a day.
• Must have ability to move around office and stand for prolonged periods.
• Must have ability to travel to mobile or fixed collection sites and to off-site meetings. 

EQUIPMENT USED

• Standard office equipment such as computers, telephones, copy machines, fax machines and scanners.

QUALIFICATIONS 

Education:

• Master’s degree in business, healthcare, or related field/discipline from an accredited college or university. 

Experience:

• 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. Additional experience in clinical laboratory and cellular therapy services, umbilical cord banking, molecular testing and/or clinical research preferred. 

Licenses/Certifications:

• Health Care Compliance Certification Board certification or equivalent required upon hire or commitment to obtain within one year of hire. 

Skills:

• Knowledge of operational characteristics, services and activities of a quality program and in principles and practices used in healthcare/laboratory management, governmental compliance, internal audits, risk management and/or regulatory affairs.
• Significant experience drafting policies, procedures and other guidance documents.
• Ability to approach challenges with confidence.
• Ability to understand and develop business process and controls.
• Ability to perform accurate detail-oriented work.
• Strong oral/written communication and presentation skills.
• Strong leadership, organizational, interpersonal and analytical skills and the ability to function effectively in a fast-paced environment.
• Ability to effectively facilitate change and work collaboratively with individuals at all levels and with varying backgrounds within the organization.
• Experience in trending and analyzing data, and executive reporting.
• Proven ability to meet deadlines, including time-sensitive tasks.
• High degree of sensitivity and tact in dealing with difficult or stressful situations.
• Ability to prioritize and plan work, both for self and for direct reports.
• Ability to interact with all levels of management.
• Ability to anticipate potential issues and proactively respond.
• Good judgment and problem-solving skills.
• Ability to maintain confidentiality.
• Must have good knowledge of standards and regulations that apply to blood banking, umbilical cord banking, cellular therapy services, clinical laboratory and clinical research.
• Strong working knowledge of Microsoft Office products, including Word, PowerPoint and Excel.
• Ability to learn and administrate various online databases.

The above statements are intended to describe the general nature and level of work being performed. This job description is not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified.