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Octapharma Plasma, Inc. · 14 hours ago

Regional Director 1

Florida, United States

Full-time

Onsite

Lead/Staff, Director/Executive

5+ years exp

Octapharma Plasma, Inc. is a leading company in the plasma collection industry, dedicated to creating life-saving medicines for patients worldwide. The Regional Director is responsible for overseeing center operations, ensuring compliance with regulatory requirements, and managing the financial performance of the region.

BiotechnologyHealth CarePharmaceutical

Responsibilities

Develops and fosters a philosophy of continuous improvement in all centers. Implements and consistently promotes the philosophy that compliance in quality, safety and training is essential to successful operations. Leads centers in identifying, reviewing and establishing plans to eliminate risk associated with quality and safety non-compliance

Assists center management in preparing for audits and provide direction in development of written responses. Host audits as necessary. Meets with center management team to review root cause and develop corrective action plans utilizing appropriate tools to ensure operational, quality and regulatory compliance. Develops processes to ensure that corrective action plans are fully administered. Analyzes tracking and trending data and determines appropriate action

Responsible for all aspects of financial oversight for the Region, including approving the Regional annual budget, ensuring monthly financial targets are met and providing on-going cash management

Responsible for meeting the established regional production goals and ensuring that all center inventories are managed to the optimum levels by maximizing efficiencies, customer service levels and minimizing investment. Ensures that all centers are monitoring net yields and implementing plans for improvement when required

Responsible for assisting Center Management with recruitment, training, development, counseling and termination. Directly supervises management trainees assigned to the region

Qualification

Financial oversightCGMP knowledgeFDA regulationsQuality control principlesSupervisory experienceBilingual in SpanishInterpersonal skillsWritten communicationVerbal communication

Required

Must be able to speak, read, write and understand English

Demonstrated expertise and knowledge of cGMP's, FDA and EU regulations, SOP implementations well as an understanding of quality control principles and QA audit functions

Demonstrated excellent interpersonal, written and verbal communication skills

Ability to sit or stand for extended periods for up to four (4) hours at a time

Ability to tug, lift, and pull up to twenty-five (25) pounds

Be able to bend, stoop or kneel

Occupational exposure to blood borne pathogens

Ability to view video display terminal less than 18” away from face for extended periods of time, up to four (4) hours at a time

Travel approximately 75% of time

Preferred

B.S. or B.A. degree preferred. Other combinations of education and experience may be considered

Relocation flexibility is preferred

Five (5) years job-related experience in a biologics, drug manufacturing, medical device or FDA regulated laboratory facility including a minimum of 1 year related experience in a plasma donor center is preferred

Minimum three (3) years of supervisory experience. Experience in a matrix organization is preferred

Bilingual skills in Spanish are preferred in some locations