Sr. Director, Manufacturing Sterile Operations

Job Description

Overview:

The Sr. Director, Manufacturing Sterile Operations is accountable for driving results in a fast-paced environment by providing leadership to the site’s manufacturing function. Focus areas for the role include operational leadership, parenteral (Filling and Visual Inspection) manufacturing processes, project management, continuous improvement, change management, manufacturing investigations/corrective actions, participation in business reviews, and support of regulatory and client audits.

Responsibilities:

• Directs and leads the Manufacturing team to deliver on the schedule of four aseptic isolator fill lines and visual inspection to meet company and client demand.
• Leads manufacturing and cross functional support teams with Lean Six Sigma/ continuous improvement mindset and principals to achieve higher quality, compliance, and productivity goals.
• Develops information and produces reports concerning scheduling, production goals, equipment and maintenance problems and other studies or reports as requested.
• Provides manufacturing information by compiling, initiating, sorting, and analyzing production related records and data to key stakeholders.
• Ensures all manufacturing discrepancies are captured with appropriate documentation and then works collaboratively with appropriate personnel to facilitate client communication per quality agreements.
• Accountable for accurate and timely completion of all department investigation reports and the effective and timely corrective/preventative action (CAPA) implementations and follow-up.
• Accountable for the accurate and timely completion of all manufacturing processes and documentation (Manufacturing Batch Records and Quality Records) and "Right First Time" performance goals.
• Responsible for setting strategic direction and administration of Manufacturing.
• Responsible for budgets, forecast, and long-term planning and development of human and manufacturing resources.
• Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
• Attracts, develops, and retains a high performing team to meet the current and evolving needs of the business through effective selection, training and development, coaching and mentoring and performance management.
• Other duties as assigned.

Qualifications:

• Bachelor’s degree required (Science or Engineering related preferred).
• 6+ years of management experience required.
• Prior pharmaceutical experience in sterile aseptic filling and visual inspection is required;
• Solid understanding of FDA and ANEX 1 aseptic guidelines and regulations.

Prior experience with final product release, major equipment validation, validation protocol review, process validation protocol review, 21 CFR Part 4/ISO 13485 and APRs preferred