Associate Director, Quality Process Excellence- Alpharetta Location

POSITION OVERVIEW

This position provides support of quality operations activities at the Alora sites to ensure quality and regulatory requirements are achieved (21 CFR 210, 211, and Part 11).  The sites include Alpharetta, GA, Marietta, GA, Fort Worth, TX, Sayreville, NJ, and Tampa, FL.  The person in this role will direct process improvement projects and act as a project manager to ensure the sites stay on track for completing critical compliance activities.

DUTIES AND RESPONSIBILITIES

• Travel to Sites 50% / Remote 50%
• Provide support to global operations quality by directing quality operations process improvements at any site in the network to ensure product quality and adherence to cGMPs
• Provide project management support to keep quality staff on track for process improvements
• Set up project teams / create charters as needed through the global operations quality network
• Recommend opportunities for increased quality system efficiencies and operational improvement through modifications to current systems and implementation of new systems
• Travel to specific sites that require more implementation activities and guidance
• Collaborate with the Global Quality Systems Management team to implement best practices and global policies
• Collaborate with the Global Supplier Quality team to make site improvements from internal audit findings
• Coordinate priorities across multiple projects and site activities
• Assist with electronic systems implementation at the sites, coordinating activities and tracking the project(s) until completion
• Assist with collecting / reporting data that demonstrate site conformance with global metrics
• Set up data reporting processes across the sites to ensure standardization and ease of use
• Perform other duties as required

EXPERIENCE AND QUALIFICATIONS

• Bachelors of Science degree in related scientific discipline (e.g., chemistry, biochemistry, etc.)
• Six Sigma Black Belt Professional (SSBBP) or Process Improvement Excellence Certified (PIEx)
• 10 years in quality or project management experience in pharmaceutical or related industry
• 5 years leadership or managerial experience in pharmaceutical or related industry
• Working knowledge of GMP pharmaceutical production, laboratory compliance, regulatory requirements, quality systems, and best industry practices
• Working knowledge of FDA guidance, as well as USP, ICH, ISPE and other industry-related guidance
• Demonstrated leadership skills
• Ability to think strategically, including the evaluation and management of risk
• Ability to manage multiple projects simultaneously while performing day-to-day activities
• Self-motivated team player with exceptional organization, follow-through, time management, and communication skills
• Excellent interpersonal skills and ability to effectively interact with different functional groups at all levels of management in the company
• Proficient in project management software and MS Office suite

Preferred Experience / Skills

• Master of Business Operational Excellence, Master of Science Operational Excellence, or other related advanced degree
• Experience in solid and liquid oral dosage pharmaceutical production