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. 

Main Responsibilities

Leadership

• Liaise with the global Infection Prevention team, marketing/sales organization, R&D and other internal customers to ensure that the existing Pharmaceutical Quality requirements are known and controlled at the plant and at critical suppliers.
• Provides project support for key deliverables and partners with regional representatives for the global expansion of the product portfolio.
• Functions as the key leader in developing the quality operational strategy and execution plans for the site in global matrix management of other departments/functions that perform activities on behalf of the site as the l alignment with the site operations leader. and primary owner of the site quality plan.
• Exercises legal manufacturer (i.e., pharmacovigilance, complaint handling, field action etc.).
• Demonstrates forward thinking leadership that drives continuous proactive engagement of the QA team.
• Collaborates with R&D department to transfer new design engineering products into manufacturing.
• Manages inspection readiness programs and activities for the site, ensuring an inspection ready state.
• Proactively assesses quality issues to determine impact to in the field and ensures they are addressed in a timely manner.
• Proactively engages with appropriate teams to secure the GMP certification of the site as well as those of critical suppliers.
• Recruits, retains, trains, develops, and leads the Quality talent in support of the Quality Management System, manufacturing, and the Business Unit strategy.
• Supports a strong culture of empowerment, accountability and inclusion and seeks to develop team capabilities as well as foster personal growth.

Quality Site lead

• As the management representative, establishes and maintains a Quality Management System to ensure the manufacturing facility, analytical laboratory, warehouse and distribution and other functional areas (as required) remains fully compliant with Good Manufacturing Practices and other applicable global regulatory requirements.
• Ensures GMP compliance of products, including defining applicable manufacturing quality standards, establishing appropriate testing methods and procedures, establishment/support of manufacturing and engineering requirements to improve design for manufacturability, deviations and reworks when/if applicable.
• Responsible for approval of the batch record files to ensure the batches are in compliance with the applicable GMP regulation before shipping.
• Assumes global responsibility for Qualified Personnel communication and support.
• Provides timely support when requested by all global organizations in supporting the preparation of necessary quality documents to support the Infection Prevention platform products.
• Oversees quality assurance of each subcontracted activity by maintaining up to date Quality Technical agreements with critical suppliers and an audit plan based on the risks associated with each supplier.
• Manages product and process quality reports /metrics collecting, analyzing, and summarizing information and trends and proactively driving improvements.
• Plans, coordinates, leads and/facilitates internal and external audits and provides leading role support during Health Authority inspections. Ensures the necessary response efforts for inspections are executed per requirements and timelines.
• Manages timely and robust execution of all QMS elements including change control, CAPA, complaint investigations, out of specification investigations, out of trend investigations, non-conformances, and training compliance.
• Complies with all Business Unit and Corporate policies, standards, and procedures.

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.

Why Join Us?

A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.  

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.  

To learn more about BD visit https://bd.com/careers 

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. 

Required Skills

Optional Skills

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Primary Work Location

USA TX - El Paso - Northwestern Dr.

Additional Locations

Work Shift