Job Description Summary

Job Description

Overview

• This role directly impacts global revenue, supply continuity, regulatory status, and OUS business strategy of the global Infection Prevention planform .
• The Director 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, the Director establishes, leads and maintains a Quality Management System, ensures the site is in full compliance with regulatory and industry requirements and standards. She/He plans, coordinates, manages and/or facilitates internal and external audits/inspections and provides leadership during regulatory authority visits.
• The Director leads quality programs, continuous improvement efforts, and provides quality review, guidance and recommendations associated with all efforts at the site. She/He is responsible for ensuring that all planned and unplanned quality & compliance issues are addressed.
• 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.

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, nonconformances 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 with a minimum of 3-years experience directly leading people required.
• 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

• 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.
• Excellent organizational skills with proactive management of multiple tasks of varied complexity..
• Negotiation and strong persuasive abilities, diplomacy, and positive influencing abilities.

Primary Work Location

Additional Locations

Work Shift