Associate Director – Quality, Compendial Compliance & Analytical Changes

Job description

Job Description Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements.  Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe. **Essential function(s) includes, but is not limited to:** - Manages organizational/functional support for activities such as: Analytical Standards and analytical change control, new products, in-line products, packaging, outsourcing, divestitures, compendial compliance, etc. - Provides quality oversight for our Manufacturing Division manufacturing sites and laboratories, Regulatory, Divisional Stability, External Quality, Procurement, our Research & Development Division, Technical Operations, etc. - Performs the appropriate document review, change control and support activities associated with their position and ensures work is in compliance with all regulatory expectations. - Supervises junior staff members and manages appropriate group functions/activities including prioritization of work, resource allocation and issue resolution. - The incumbent is responsible for assuring the application of and conformance to, current Good Manufacturing Practices. - The incumbent is also responsible for providing input for compliance and organizational objectives as well as for recruiting and mentoring highly technical scientific personnel. **Primary activities include, but are not limited to**: 1.  Supervises and ensures the coordination and maintenance of product, active ingredient, intermediate, raw material, and component Analytical Standards. This may include, but is not limited to addition/deletion/modification to analytical methods, specifications, product numbers, and product descriptions. Ensures that all Quality Standards are maintained in accordance with established divisional and departmental procedures and issued in a timely fashion. 2.    Ensures and provides Analytical Standard support and coordination for new product introductions and registrations including AS representation in new product teams (Quality, Analytical, and/or Regulatory Sub-teams). Ensures all activities associated with documents are performed in an accurate and timely manner including appropriate reviews, approvals, and issuance of documents. 3.    Supervises the coordination, evaluation, disposition and implementation of all Analytical Standard changes/modifications in accordance with the Change Request - Analytical (ACR) process. Evaluates and investigates ACRs to determine impact, appropriateness, and prioritization. 4.    Ensures the review, approval and issuance of Analytical Standards are performed in a timely manner and in compliance with departmental practices and GMP regulations. 5.    Supervises and aids in the establishment and implementation of guidance, procedures and direction for all departmental activities. 6.    Strategically, seeks to identify, develop, and employ continuous improvement ideas to benefit the department, organization or division. Provides project leadership and management for departmental and inter-departmental projects. Balances activities from a business and science perspective. Participates in divisional and inter-divisional meetings/committees/activities. 7.    Ensures appropriate level of support and service is provided to all customers and business stakeholders. 8.    Administers company personnel policies as they apply to group members including the hiring, recommendations of merit and promotional increases and performance management. Recruits, selects, develops and retains high caliber scientific personnel to meet company objectives while adhering to all employment and diversity principles. 9.    Provides direction and guidance for direct reports, ensures the application of the Performance Management System through establishing clear performance objectives, accurately assessing strengths and developmental needs of employees; effectively training and developing all team members in support of employee development and organizational planning processes; recognizing and rewarding significant achievements. Provides developmental feedback, coaching, and/or mentoring when necessary; in a positive and productive manner, using feedback to help others improve and succeed. **Education Minimum Requirement:** BS degree required, concentrations in life sciences, engineering or related relevant discipline **Required Experience and Skills:** - Minimum of 15 years applied professional work experience working in one or more of the following areas: Change Control, Laboratory Operations and/or Quality operations with laboratory oversight. - Strong technical knowledge and high level of technical performance - Understanding our Manufacturing Division change control environment and systems - Ability to lead and work well in teams, managing multiple projects/tasks simultaneously with competing priorities - Strong collaborative and communication skills - Demonstrated leadership skills and behaviors, including enterprise mindset, accountability, inclusion, sound judgment, resilience, decision quality, and the ability to influence and align cross-functional stakeholders across Quality, Regulatory, Manufacturing, Technical Operations, External Quality, Procurement, and Research & Development. - Strong business acumen with the ability to balance compliance, scientific rigor, operational priorities, risk management, cost, service levels, and supply continuity while making decisions in a regulated pharmaceutical environment. - Proven ability to build, coach, and develop high-performing scientific and quality professionals through clear objectives, technical capabi