This biopharmaceutical firm is steadfastly dedicated to producing top-notch treatments for people with compromised immune systems who are susceptible to infections. Our passion for this neglected community is what drives us, and what makes us unique is our hands-on approach to development and production. Take this company into consideration if you're searching for a biopharmaceutical company that is growing, innovative, and dedicated to excellence and integrity. They are currently in need of a Senior Director, Quality Systems and Audits available in Boca Raton, FL!
Leading the department to ensure that compliant Quality Management Systems and internal and external auditing programs are established and maintained in compliance with applicable company and US/international regulatory requirements, standards, guidance, and procedures for the development of drugs and biologics is the responsibility of the Senior Director, Quality Systems and Audits position. Control, lead, supervise, and constantly enhance Quality Management Systems, encompassing Change Controls, CAPAs, Deviations, and Internal and External Audits. oversees the management of major operations and quality initiatives at the Boca facility, as well as projects pertaining to FDA inspectional reactions. Quality improvement and root cause analysis in relation to regulatory inspections, internal audits, third-party audits, OOS investigations, deviations, and CAPAs, when necessary, are additional crucial responsibilities.
Qualifications:
Outstanding communication skills both in writing and speaking
Proven capacity for methodical and critical thought
Skilled in risk assessment and root cause analysis tools;
Capable of implementing compliant, streamlined processes using LSS tools and methodology to ensure enhanced compliance to cGMPs and changing FDA expectations;
Capable of managing budget and resources and overseeing a department.
A minimum of five years as a team/department leader with demonstrated success in coaching, mentoring, and enhancing the overall performance of the team as measured by standard metrics; a bachelor's degree in science or a related technical field;
A minimum of fifteen years of experience in the biologics pharmaceutical industry (CBER Regulated)
Five to ten years of experience in quality management are also required.
Benefits:
In addition to competitive compensation, we offer a comprehensive benefits package including:
401K plan with employer match and immediate vesting
Medical, Vision, Life and Dental Insurance
Pet Insurance
Company paid STD and LTD
Company Paid Holidays
3 Weeks' Paid Time Off (within the first year)
Tuition Assistance (after the first year)
Easily accessible to Tri-Rail
Free shuttle to the Boca Tri-Rail station
