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 ba