Director, Manufacturing Operations

Quva • Bloomsbury, NJ

4d • $163,764 - $225,175

About The Position

Our Director, Manufacturing Operations plays a vital role in ensuring the highest quality and safety standards of our pharmaceutical products. Once you complete our training, your responsibilities will include overseeing the support of site and company-wide objectives through the reporting of department Key Performance Indicators (KPI). Meeting quality, safety, delivery, and productivity objectives. Ensures people and processes comply with current Good Manufacturing Practices and company procedures. The Director, Manufacturing Operations, is also responsible for: The support of site and company-wide objectives through the reporting of department Key Performance Indicators Ensuring people and processes comply with current Good Manufacturing Practices and company procedures Modifies department standard operating procedures and executes change controls to support business and quality objectives Establishes and maintains cooperative cross-functional relationships with peers in Quality, Operations, Technical Support, Pharmacy Services, Research & Development, and Supply Chain to meet site and corporate objectives What the Director, Manufacturing Operations Does Each Day: Direct and plan the overall company’s pharmaceutical production operations Runs operation to meet or exceed delivery performance and customer service objectives Establish and ensure that cGMP compliant policies, processes, procedures and best practices are developed and consistently executed across the manufacturing operations and provide support and guidance on policy related matters Counsels and develops colleagues for efficient performance; provides constructive feedback; creates an atmosphere of team effort and open communication Ensure that all production areas have the processes, equipment, and adequately trained staff to support the continuing growth goals of the company and meet customer demand Troubleshoots and resolves issues impending deliverables; proactively demonstrates the ownership to achieve Maintain and report key performance indictors and escalate any identified risks to permit timeliness to remain contiguous Maintain a contemporaneous working knowledge in cGMP requirements Other duties that may reasonably be assigned from time to time by the company This is a security-sensitive position as the incumbent works with controlled substances and therefore will be subject to periodic drug screen per company policy Consistently promote and support best practices involving work methods (lean methodology), technology, and operational systems in order to remain innovative and to maintain and/or increase quality of production methods and final product quality Provide leadership and direction to team to assure consistently high levels of performance in pharmaceutical operations Lead employees to meet the organization’s expectations for safety, quality and productivity goals Manage the overall operational, budgetary, and financial responsibilities and activities of the manufacturing operations departments Provide input towards the selection, hiring and placement of personnel within the departments as needed Actively participate in performance evaluations Other duties as assigned Our Most Successful Director, Manufacturing Operations: Has outstanding written, oral communication skills Can organize large volumes of data Is experienced in pharmaceutical manufacturing especially sterile injectable Manages multiple, parallel projects Is an expert in Pharmaceutical manufacturing

Requirements

• BA/BS Degree in Business, Science or related field or significant experience
• 5 years’ experience in managing a cGMP manufacturing plant operation required
• 7-10 years of related experience in cGMP/FDA regulated industry (CFR 201 & 211 emphasis on FDA guidance for industry aseptic processing preferred)
• Demonstrated experience and leadership in cGMP compliance audits and inspections required
• Demonstrated knowledge of lean manufacturing and metric concepts preferred
• Demonstrated ability to increase others knowledge of cGMP regulations and guidance preferred
• Proficient in computer skills. (e.g. Microsoft Office suite: Visio, ERP systems, MS Project)

Nice To Haves

• Has outstanding written, oral communication skills
• Can organize large volumes of data
• Is experienced in pharmaceutical manufacturing especially sterile injectable
• Manages multiple, parallel projects
• Is an expert in Pharmaceutical manufacturing

Responsibilities

• Overseeing the support of site and company-wide objectives through the reporting of department Key Performance Indicators (KPI)
• Meeting quality, safety, delivery, and productivity objectives
• Ensuring people and processes comply with current Good Manufacturing Practices and company procedures
• Modifies department standard operating procedures and executes change controls to support business and quality objectives
• Establishes and maintains cooperative cross-functional relationships with peers in Quality, Operations, Technical Support, Pharmacy Services, Research & Development, and Supply Chain to meet site and corporate objectives
• Direct and plan the overall company’s pharmaceutical production operations
• Runs operation to meet or exceed delivery performance and customer service objectives
• Establish and ensure that cGMP compliant policies, processes, procedures and best practices are developed and consistently executed across the manufacturing operations and provide support and guidance on policy related matters
• Counsels and develops colleagues for efficient performance; provides constructive feedback; creates an atmosphere of team effort and open communication
• Ensure that all production areas have the processes, equipment, and adequately trained staff to support the continuing growth goals of the company and meet customer demand
• Troubleshoots and resolves issues impending deliverables; proactively demonstrates the ownership to achieve
• Maintain and report key performance indictors and escalate any identified risks to permit timeliness to remain contiguous
• Maintain a contemporaneous working knowledge in cGMP requirements
• Consistently promote and support best practices involving work methods (lean methodology), technology, and operational systems in order to remain innovative and to maintain and/or increase quality of production methods and final product quality
• Provide leadership and direction to team to assure consistently high levels of performance in pharmaceutical operations
• Lead employees to meet the organization’s expectations for safety, quality and productivity goals
• Manage the overall operational, budgetary, and financial responsibilities and activities of the manufacturing operations departments
• Provide input towards the selection, hiring and placement of personnel within the departments as needed
• Actively participate in performance evaluations
• Other duties as assigned

Benefits

• Comprehensive health and wellness benefits including medical, dental and vision
• 401k retirement program with company match
• A minimum of 25 paid days off plus 8 paid holidays per year
• National, industry-leading high growth company with future career advancement opportunities

What This Job Offers

• Job Type: Full-time
• Career Level: Director