Associate Director, Quality

Quality Environmental Monitoring Associate DirectorThe Quality Environmental Monitoring (EM) Associate Director 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.Key Responsibilities: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 workstreams across dynamic operational areas.Technical writing skillsets, ongoing independent management of variation of project workstreams, and ongoing authorship, review and/or quality approval of project workstreams 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 workstreams 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 workstreams 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 control is achieved.Effectively can identify where continuous improvements opportunities exist, both in response to events, as warranted per trends in metrics, and proactively, to ensure sustainment and improvement of environmental control and high-quality operations.Actively works to improve quality and related processes to ensure standardization, efficiency, and compliance across EM Team, E2E IPTs, E2E's across site, as applicable. Is mindful and will be challenged to identify and develop innovative ways of working, proactively and for cause.Aides and/or oversee the review of daily Out of Specification Report and works with Deviation Management (DM) and other cross functional groups to evaluate/address associated events; this includes attending DM Tier(s) and other related meetings, active participation in deviation investigative processes, evaluation and development of corrective and preventative action, and routinely as needed, going to operational floor for assessment / completion of assigned tasks.Manages data and related information for E2E IPTs, as applicable to routine environmental performance assessments, against testing result specifications for classified areas.Can generate, comprehend, and analyze data and identify trends.Attention to detail and capability to author accurate detailed assessments of information is expected.Manages projects for process simulations, media holds, and special studies for assigned E2E IPTs, and concurrently participates in related workstreams.Manages the per process EM testing plans for applicable areas across E2E IPTS.Participates, leads, and/or manages assigned workstreams from EM Center of Excellence compliance and continuous improvement workstreams, applicable to the West Point EM Program and E2E IPTS.Learns, is knowledgeable, and capable of conducting Risk Based EM Assessments of on the floor EM sampling points and data/information comparisons, and other related tasks such as test site map updates and change control.Learns, is knowledgeable, and capable of representing EM quality role in the E2E IPTS Quality Risk and Gap Assessments, as applicable to compliance for conducting on a frequency basis and for-cause.Manages process and data related change requests for E2E IPTs.Manages workstreams for authoring new and revised SOPs and related documentation generated for or originating from E2E IPTS, as applicable to authorship, quality review, and/or quality approval.Leads and/or assists with phased training and on-going coaching of new and cross functional personnel, including but not limited to deviation management, EM investigations, EM program, GLIMS change control, process change control, and inspection support for E2E IPTS.Education Requirements:Bachelor's degree in Microbiology, Biology, Chemistry, or other technical related scientific areas of study (technical operations, deviation management).Required Experience and Skills:Minimum six (6) years of pharmaceutical quality, or related field of expertise (technical operations deviation management experience; this includes experience working within classified areas.Must be able to manage diverse quality related assignments (planned and unplanned) in independent, organized, and concurrent manner, while adhering to compliance requirements and strict timelines, across applicable E2E IPTs.Demonstrates versed skillsets in leadership and is comfortable and effective at communicating and independent decision-making, as applicable, across all levels of management, including upper management and cross-functional groups.Demonstrates immediate capability to lead assigned workstreams in independent and cross-functionally; can interact effectively with leadership.Strong understanding of CGMPs, FDA, and EMEA regulatory standards and strong compliance mindset; comprehension and use of these standards is to support the compliance and eventual sustainment of ongoing large-scaled projects, as warranted.Demonstrated leadership and management experience working with cross-functional teams on objectives to deliver on Key Performance Indicators, meet significant project milestones, and lead an organization to meet priorities for the year.Preferred Experience and Skills:Technical writing expertiseExperience working with Laboratory Information Management SystemsExperience in technical operations deviation managementKnowledgeable of Lean Leadership PrinciplesExperience managing direct reportsRequired Skills:Aseptic Processing, Aseptic Processing, Audit Management, cGMP Training, Communication, Customer-Focused, Detail-Oriented, Driving Continuous Improvement, Environmental Controls, Environmental Monitoring, Ethical Standards, GMP Compliance, Leadership, Microbiology, Molecular Microbiology, Multi-Management, Preventive Action, Process Simulation, Project Development, Project Management, Quality Control Documentation, Quality Management, Quality Management Systems (QMS), Quality Metrics, Quality Risk Management {+ 5 more}Preferred Skills:U.S. Hybrid Work ModelEffective September 5, 2023, employees in office-based positions in the U.S. will