What are the responsibilities and job description for the Manager, Quality and Regulatory Affairs position at San Diego Blood Bank?
Position Title: Manager, Quality & Regulatory Affairs
FLSA: Full-time, Exempt (salaried) plus benefits
Salary: $96,500 - $123,500 annually (depending on experience)
Schedule: Monday - Friday; 8:00 am to 5:00 pm
Location: SDBB HQ – 3636 Gateway Center Ave, Ste 100, San Diego, CA 92102
Are you passionate about making a real difference in your community? Are you looking for a job where you can contribute to a meaningful cause and grow professionally? If so, San Diego Blood Bank invites you to join our dynamic & diverse team dedicated to the mission of saving & improving lives through blood and biotherapies.
WHY CHOOSE SDBB?
At San Diego Blood Bank, we provide Southern California regional hospitals with a wide range of blood banking services. These include blood collection, component preparation, plateletpheresis, plasmapheresis, leukapheresis, washed blood, frozen blood, autologous storage, designated donation services, and a reference laboratory. San Diego Blood Bank’s Cord Blood Banking Program provides lifesaving stem cell transplants to patients worldwide.
At San Diego Blood Bank, we provide Southern California regional hospitals with a wide range of blood banking services. These include blood collection, component preparation, plateletpheresis, plasmapheresis, leukapheresis, washed blood, frozen blood, autologous storage, designated donation services, and a reference laboratory. San Diego Blood Bank’s Cord Blood Banking Program provides lifesaving stem cell transplants to patients worldwide.
Founded in 1950, San Diego Blood Bank has been an important institution in the San Diego community for decades. Today, SDBB is continuing to grow to meet the changing needs of our healthcare community.
San Diego Blood Bank is a 501(c)(3) nonprofit organization also operating as Southern California Blood Bank. We serve hospitals in San Diego, Los Angeles and Orange Counties. We are the primary blood provider to Rady Children’s Hospital-San Diego and the safety net for hospitals in our region. Every year, more than 150,000 units of blood provided by San Diego Blood Bank are transfused into patients of all ages, socio-economic and ethnic backgrounds throughout Southern California. These patients are struggling with life-threatening medical conditions including cancer and other blood disorders, severe burns, organ transplants, emergency surgery, trauma, childbirth complications and more.
WHAT YOU NEED TO KNOW (Job Summary)
WHAT YOU NEED TO KNOW (Job Summary)
Assists the Chief Quality, Regulatory Affairs, and Risk Officer and the Director, Compliance and Regulatory Affairs with developing, implementing, and executing quality assurance processes and practices that support the manufacture of FDA regulated biologic, cell and tissue products and related regulatory activities. Assist in managing and monitoring systems and processes, in support of the San Diego Blood Bank Quality and Compliance programs, promoting an organizational culture of excellence. Ensures that performance and quality of products conform to established standards and regulatory requirements. Requires excellent leadership skills and an ability to foster teamwork and collaboration. Must be able to analyze complex issues, work independently, and have the flexibility to meet changing business and stakeholder needs.
WHAT YOU WILL BE DOING TO MAKE A DIFFERENCE (Key Responsibilities):
- Embody and promote an overall culture of compliance that encourages ethical conduct and a commitment to compliance with laws, regulations, and standards.
- Review, assess, and monitor quality assurance programs, policies, processes, procedures, and controls ensuring that performance and quality of products conform to establish standards and regulatory requirements.
- Perform regulatory review and approval of standard operating procedures, validations, and other regulated documents.
- Develop and revise policies, standard operating procedures, and other regulated documents.
- Assist in the maintenance and improvement of the San Diego Blood Bank quality and compliance programs.
- Prepare audit tools, conduct internal audits, submit audit reports, and perform follow up on related corrective action plans.
- Host and/or assist departments in preparing for external inspections/assessments/audits.
- Coordinate quality assurance and compliance-related activities with department management and staff.
- Manage and lead Quality Assurance and Compliance Specialists, Quality Assurance and Compliance Associates and Data Entry Personnel in developing metrics and key performance indicators for areas of responsibility in order to constantly monitor and raise standards of performance.
- May serve as Administrator for the quality management system.
- Analyze data, identify trends and report findings to management.
- Participate in corrective and preventative action teams, assist with investigation and root cause analysis and verify that actions are implemented and effective.
- Assist with developing and the implementation of performance improvement initiatives.
- Determine if a recall, market withdrawal, regulatory and consignee notification is necessary due to deviations or positive test results.
- Participate in appropriate departmental meetings and attend other meetings as assigned.
- Enhance professional growth and development through participation in educational programs, current literature review, in-service meetings, and workshops.
- Represent the San Diego Blood Bank at conferences and meetings as assigned.
- Performs other related duties as assigned or requested.
WHAT YOU NEED TO SUCCEED (Minimum Qualifications)
- Bachelor’s degree in a related field, or equivalent combination of education, training and experience. Advanced degree preferred.
- Minimum of four (4) years in a supervisory or management position.
- Must have related experience. including participation in FDA and State site inspections, experience with GMP requirements, application of quality assurance principles, and healthcare compliance. Additional experience in cellular therapy services, umbilical cord banking, molecular testing and/or clinical research preferred. Auditing experience preferred.
- ASQ, CPHQ, or Health Care Compliance Certification Board (CHC, CHRC) certification required upon hire or commitment to obtain within one year of hire.
Skills:
- Strong working 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, or regulatory affairs.
- Ability to approach challenges with confidence.
- Ability to perform tasks per GMP regulations including following detailed SOPs, maintaining training, deviation reporting and good documentation practices.
- Ability to perform accurate detail-oriented work.
- Ability to organize activities effectively, use effective problem-solving techniques and make sound decisions.
- Ability to communicate effectively with internal and external customers.
- Good organizational and time management skills; must be able to establish priorities and multi-task
- Ability to effectively facilitate change and work collaboratively with individuals at all levels and with varying backgrounds within the organization.
- Ability to maintain confidentiality.
- Must possess good verbal and written communication skills and teaching abilities.
- Must have good knowledge of standards and regulations that apply to blood banking, umbilical cord banking, cellular therapy services, clinical laboratory, and clinical research.
- Proficient in Microsoft Suite applications (Excel, Word, PowerPoint)
BENEFITS FOR YOU
We take care of you, while you take care of others. As a mission-based organization, we believe our team needs great support to do great work. Our comprehensive benefits help you in balancing home and work. With our resources and perks, you have amazing possibilities at the San Diego Blood Bank including:
- Employees working 30 or more hours per week are eligible for employer sponsored health benefits (Medical, Dental, & Vision plans)
- Earn up to 120 hours of paid vacation in your first year.
- 7 paid Holidays 1 personal holiday provided annually.
- 40 hours of paid sick time provided annually.
- 403b retirement plan with 3% employer match starting on your first day.
- Employee Assistance Program - Free for employees and their families
- Service Awards and recognition.
Apply now! Join our team to make a difference every day.
The San Diego Blood Bank is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
The San Diego Blood Bank is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
Salary : $96,500 - $123,500
