Associate Director, Quality Management and QA Site Leader

at  BD

JOB DESCRIPTION SUMMARY

This global role has the complex responsibility to address worldwide GMP standards as a Legal Manufacturer with a direct responsibility for the US market and delegated responsibility for OUS markets including additional oversight responsibilities for sterilization, failure investigations, pharmacovigilance, post market surveillance, GMP Auditing and Supplier Management.
The Associate Director, Quality Management and QA Site Leader ensures that the products manufactured meet global regulations, the registered regulatory dossier specifications, and global quality requirements.
As the Management Representative of a pharmaceutical manufacturing plant, establishes, leads and maintains a Quality Management System, ensures the site is in full compliance with regulatory and industry requirements and standards. This person plans, coordinates, manages and/or facilitates internal and external audits/inspections and provides leadership during regulatory authority visits.
The Assoc. Director leads quality programs, continuous improvement efforts, and provides quality review, guidance and recommendations associated with all efforts at the site. This s responsible for ensuring that all planned and unplanned quality & compliance issues are addressed.
This role directly impacts global revenue, supply continuity, regulatory status, and OUS business strategy of the global Infection Prevention planform.

JOB DESCRIPTION

We are the makers of possible
BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.
We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us.

QUALIFICATIONS AND REQUIREMENT:

• A bachelor’s degree in a scientific, engineering, or related area is preferred. Advanced degree (MBA, MS, or PhD) preferred.
• Minimum of 8-years’ experience working in a regulated quality environment, preferably in Pharmaceutical manufacturing, with a minimum of 3-years’ experience directly leading people preferred.
• Experience leading/facilitating internal and external audits and providing leading role support during regulatory authority inspections required.
• Experience operating as a leader with global mindset, understanding and appreciation of the global /enterprise context preferred.
• Ability to establish and maintain cooperative working relationships with internal and external partners required.
• Ability to take initiative and work independently while effectively managing timelines required.
• Ability to perform in fast paced environment and in stressful situations is required.
• Influence, shaping solutions, negotiation and consultative skills are required.
• Additional domestic travel and international travel as needed required ~20%.

KNOWLEDGE AND SKILLS

• Experience with the following regulations / standards:
• US: ISO13485, CFR 201 / 211, Data Integrity (FDA, MHRA PIC/S), CFR Part 11, ISO 13485, ICH Q7, 9, 10, 13 and 13.
• OUS: EU Directive 2001/83/EC and Regulation (EC) No 726/2004 and Annex 1- 16.
• General: Pharmaceutical Transport Regulations
• Understanding of laboratory systems/equipment (e.g., IQ/OQ/PQ) is a must with the demonstrated ability to write and/or effectively review/critique technical documents such as lab investigations with analytical, manufacturing, and regulatory content.
• Expert knowledge and understanding of compendia (USP, EP, JP, etc.), global regulations, and current Good Manufacturing Practices (cGMP) pertaining to pharmaceutical operations required.
• Strong leadership skills with strategic problem-solving ability which results in solutions and risk-based decision making.
• Excellent Bilingual English/Spanish communications and presentation skills in both written and verbal a plus
• Excellent organizational skills with proactive management of multiple tasks of varied complexity.
• Negotiation and strong persuasive abilities, diplomacy, and positive influencing abilities.
  This job description is intended as a summary of the primary responsibilities of and qualifications for this position. The job description is not intended as inclusive of all duties an individual in this position might be asked to perform or of all qualifications that may be required either now or in the future.
  At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.
  For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.