Associate Director, Quality

Job Description

The Quality Environmental Monitoring (EM) Associate Director (P4) reports to EM Quality Lead and provides direct Quality support to operational areas as part of a Quality Integrated Production Team (IPT) Operating model for assigned E2E/IPTs. With guidance from Quality IPTs Leadership team, the Associate Director will ensure compliance and quality of products/processes and perform responsibilities to facilitate the release of product to the marketplace.

• Accountable for the oversight and sustained state of environmental control per the Environmental Monitoring Plan for Classified Areas; performing job functions located in classified operational, Controlled Non-Classified areas and within office settings.

• Works closely with assigned End to End (E2E) of Operations, Quality, Deviation Management, Technical Operations, and other cross functional groups in overall team environment, and respectively as independent contributor.

• Ensures all compliance requirements are met and can manage and meet required timelines for concurrent project work streams across dynamic operational areas.

• Technical writing skillsets, ongoing independent management of variation of project work streams, and ongoing authorship, review and/or quality approval of project work streams to compile and analyze data for classified and controlled non-classified areas across E2E IPT’s are major components of job function.

• The attention to detail, executing and driving to completion work responsibilities Right First Time are expectations.

• Ensures compliance to federal and other regulatory agency requirements, cGMP (Current Good Manufacturing Practices), our companies Quality Systems and Quality Standard Operating Procedures (SOPs), Operational SOPs, and Systems Applications and Products (SAP) functions to assure a state of compliance is achieved in sustained and continuously improving manner.

• Accountable for actively adhering to, contributing, and meeting all Diversity, Equity, & Inclusion and Safety related requirements and expectations; adherence to mindset and efforts to take action are expectations across all ways of working.

• Must be capable of executing diverse work streams utilizing notable leadership and independent decision-making skillsets, and can drive project closures efficiently, while upholding ongoing compliance for high‑quality operations.

• Independently leads a variation of assignments related to regulatory commitments, deviation management, change management, quality risk and gap assessments, process simulations, media holds, continuous improvement, and other related workstream for EM Quality team.

• Will independently manage all phases of assigned projects and/or will lead and be accountable for leading other EM Quality

• Specialists in project development, management, and larger project tracking.

• Actively supports and will participate in on‑site regulatory and related inspections / audits, contributes to ongoing inspection readiness state for classified areas and EM related documentation.

• Face‑to‑face inspector interactions are to be expected.

• Authors, and as applicable reviews and/or approves documentation for event‑based multi‑phased project streams.

• Additionally, manages routine, requalification, qualification of environmental classified area(s) related project protocols, reports, and data assessments.

• Ensures assigned areas of coverage are operating in a continued state of Environmental Control (EC) and is expected to utilize tier and other escalation processes in response to adverse events, trends, and other potentially impactful events in classified areas.

• Diligently responds to and provides subject matter expertise as it relates to potentially impactful EC events; these work streams are associated with planned and unplanned activity that may warrant immediate response, at times during non‑standard business hours.

• Such events require leadership skillsets to address situations with cross‑functional representation, going into classified areas to evaluate, immediate project development, management, and other related activities to ensure immediate correction, prevention, and sustainment of environmental…