Home Office, US
22 hours ago
Director, Bio Supplies Medical Department

table.MiTabla { max-width: 1020px;!important

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

Summary:

Reporting to the Corporate Medical Director, the Director, Bio Supplies Medical Department provides medical oversight and guidance for a group source plasma, whole blood, blood component, and specialty plasma collection centers and their corresponding medical directors, laboratory directors, and center medical staff. The human-derived blood, plasma, and materials collected at these centers are used in pharmaceutical and diagnostic manufacturing, as well as in life science research. The Director may also serve as a center medical and / or laboratory director for a Bio Supplies collection center(s) with all the responsibilities pertaining to those positions.

 

Primary Responsibilities:

Be readily familiar with Current Good Manufacturing Practices (cGMP), applicable State and Federal guidelines, Occupational Safety and Health Administration (OSHA), Clinical Laboratory Improvement Amendments (CLIA), Plasma Protein Therapeutics Association (PPTA) Standards Program, AABB Standards for Blood Banks and Transfusion Services, pertinent sections of the Code of Federal Regulations (CFR) and pertinent sections of the European Regulations including but not limited to the European Blood Directives, European Directorate for The Quality of Medicines and Health Care (EDQM), European Pharmacopoeia and The Pharmaceutical Inspection Co-operation Scheme (PIC/S). Be readily familiar with the approved Standard Operating Procedures (SOP) for the Bio Supplies whole blood, blood component, and specialty plasma collection centers and maintain certification as a center medical and laboratory director with all the job responsibilities and corresponding medical licensures pertaining to those positions. Serve as a member of the Bio Supplies Business Unit Leadership Team. Provide medical oversight, guidance, and subject matter expertise to the Bio Supplies whole blood, blood component, and specialty plasma collection centers. Manage and supervise any other medical support staff for the Bio Supplies Medical Department as assigned. Conduct as needed meetings with center medical and laboratory directors. Lead the recruitment and interview process of new center medical and laboratory directors. Collaborate with the Corporate Medical Director and Corporate Legal Department to manage the contracts for the center medical and laboratory directors. Be responsible for coordinating the training and certification of new medical and laboratory directors on the applicable Standard Operating Procedures (SOPs). Provide medical expertise in the review of donor adverse events and contribute to company and industry Plasmavigilance activities. Collaborate with the Corporate Medical Director and Regulatory Affairs to lead the investigation for donor fatalities. Coordinate with regional and collection center leadership to ensure adequate physician coverage for all centers including planned or unplanned absences of the center medical and laboratory directors. Collaborate with the Corporate Medical Director to establish the expectations and goals for the Bio Supplies Medical Department. Collaborate with the Corporate Medical Director to manage the medical department budget and contribute to the annual budget planning process. Collaborate with the Corporate Medical Director and Bio Supplies Quality to identify and implement quality improvement projects for the medical department. Collaborate with the Corporate Medical Director and Bio Supplies Operational Leadership to identify and implement projects that contribute to improved operational efficiency and donor experience. Be available to assist center leadership and the Bio Supplies Quality Department, as needed, in the development of corrective action plans. Review internal and external audit reports of the Bio Supplies donor centers to assist in the formulation and evaluation of the goals and objectives of the Bio Supplies medical department. Assist the Corporate Medical Director and Training Department with the development of training manuals created for the different roles within the medical department, as well as the specialty programs. Assist the Corporate Medical Director with the regular review and update of all written medical guidelines to be used at the donor centers to maintain a homogenous approach and keep updated with regulatory changes and medical advances. Be responsible for the oversight of the preparation, conduct, and administration of a research study or other sponsored project in compliance with applicable laws and regulations and institutional policy governing the conduct of sponsored research. May serve as a Center Medical and Laboratory Director for any Bio Supplies donor center as needed. Regularly communicate with the Corporate Medical Director regarding the Bio Supplies medical department. Conduct activities in a responsible and ethical manner according to accepted medical standards to ensure donor safety and product safety. Conduct activities in accordance with Grifols' history, values and mission to ensure donor safety and product safety. May represent the company at industry associated activities and events, including the active participation in special committees and task forces as needed. May serve as an instructor at the Grifols Academy. May serve as a Center Medical and Laboratory Director at a Grifols source plasma collection center. Assists the Corporate Medical Director as needed with other duties as assigned.

 

Additional Responsibilities:

Performs Clinical Laboratory Improvement Amendments (CLIA) related Laboratory Director duties as needed. Performs at the expert level for all duties of the Center Medical and Laboratory Director. Participates in Management meetings. Provides technical direction to others. May participate in the interview process of new hires. May provide input into Performance Management Process and participate in employee performance counseling as requested and supervised by the Corporate Medical Director. Acts as a resource for others and is a designated trainer. May provide general guidance to center staff related to donor eligibility, donor safety, and product suitability. Prepare all necessary files, records, etc., to support Medical Director activities during center visits.

 

Knowledge, Skills, and Abilities:

Expertise in the medical field, and up to date with medical literature, medications and medical conditions. Knowledge of current cGMP and SOPs, Federal and State regulations as they relate to biologics. Excellent oral and written communication skills. Must have excellent ability to multi-task, organize work, and prioritize competing demands. Must be able to work independently and with little supervision. Strong quantitative and analytical skills. Strong critical thinking and problem-solving skills. Ability to analyze and interpret data, identify errors, and prepare reports. Must be able to assess and trouble shoot problems, adapt to multiple changes, last minute requests, and manage highly educated individuals remotely. Ability to relate and interact with a diverse population with heterogeneous social and educational backgrounds. Thorough quality and excellent proficiency in all duties with ability to handle the most complex and difficult duties. Excellent caregiver, diagnostic, and customer service skills. Strong assessment skills with ability to handle all donor eligibility determinations. Excellent Customer Service and interpersonal skills. Good understanding of both verbal and written English. Where applicable written and verbal bi-lingual skills. Ability to understand and follow SOPs and protocols. The ability to organize, prioritize and complete daily, weekly and monthly tasks in a high paced, highly regulated environment following strict protocols in regard to audits and detailed documentation. Has the skills to delegate when appropriate. Computer proficient in web-based training and Microsoft Office.

 

 

Education and Experience:

Medical Degree (MD or DO) required. Current, unrestricted physician license in the State of work required and licensing in multiple states may be requested as needed. Board certified in Clinical and / or Anatomic Pathology required. Board certified in Blood Bank / Transfusion Medicine preferred. Typically requires 5 years of related experience. Skill, competency and performance as Center Medical Director, as well as prior experience in a leadership position may be considered in place of the stated requirements. For example: a physician who has demonstrated excellent control of the medical operations of the donor center, or a physician who has also managed a medical clinic, a team in an urgent care or similar setting, or other applicable leadership experience, may be considered in lieu of 5 years of experience in the plasma industry. These cases are evaluated and approved exclusively by the Corporate Medical Director.

 

The estimated pay scale for the Director, Bio Supplies Medical role based remotely is $230,720.00 - $346,080.00 per year. We offer a wide variety of benefits including, but not limited to: Medical, Dental, Vision, PTO, up to 5% 401(K) match and tuition reimbursement. Final compensation packages will ultimately depend on education, experience, skillset, knowledge, where the role is performed, internal equity and market data. We are committed to offering our employees opportunities for professional growth and career progression. Grifols is a global healthcare organization with employees in 30 countries focused on patient health and providing impactful results. Since our humble beginnings in 1909, Grifols has been a family company that prides itself on its family-like culture. Our company has more than tripled over the last 10 years, and you can grow with us!

 

Third Party Agency and Recruiter Notice:

Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.

 

Grifols provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other characteristic or status protected by law. We will consider for employment all qualified Applicants, including those with arrests or conviction records, in a manner consistent with the requirements of applicable state and local laws, including the California Fair Chance Act, the Los Angeles County Fair Chance Ordinance for Employers, and City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.

 

Location: NORTH AMERICA : USA : Home Office:USHOME - Home Address 

 

Learn more about Grifols

 

Confirm your E-mail: Send Email