Plant Manager

Plant Manager

Our client, a global leader in the development and manufacturing of injectable and inhalation products, is looking for a Site Head to lead their growing manufacturing facility.

Essential Duties and Responsibilities

• Responsible to meet corporate production goals
• Reviews production volumes vs. budget and demand on a periodic basis
• Ensures that the OTIF is met
• Conducts periodic review of quality and safety systems
• Ensures audit readiness & compliance 24*7
• Ensures that the site is aligned to internal standards and external regulations related to cGMP, Safety, Quality and Homeland security
• Ensures site response and compliance to all audit observations and customer complaints
• Ensures EAP plan is in place for site
• Coordinates with cross functional teams (Quality, SCM, Finance etc.) for the various site related activities and ensures that any issues identified are resolved
• Collaborate with Finance group to oversee, prepare and manage the site budget, with overall site P&L responsibility
• Ensures effective utilization of OPEX budget & keeps expenses under control
• Drives change across the team through various initiatives like MANTHAN, Lean/AET, cross functional project teams, and ensures implementation of changes needed to deliver the identified objectives
• Initiates any special projects as needed, as per business / statutory / legal requirements
• Leads implementation of these approved projects within the given cost and timelines
• Ensures induction, learning and development, training, performance management and engagement for the team. Identifies successors and mentors them accordingly
• Collaborate with HR to develop human capital strategies, including training plans and communication of company values, policies and procedures
• Direct and coordinate site operations to remain in accord with all company policies and procedures

Key Competencies (knowledge, skills and abilities every person must possess to be successful)

• Critical Thinking — using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems
• Strong working familiarity with FDA, ICH, EPA, DEP, OSHA, RMP, PSM, and DHS regulation
• Experience dealing with outside regulatory and community agencies and employment law
• Knowledge and application of chemical processes reactions, bottle filling & labelling process, specifically in the pharmaceutical industry
• Knowledge and Application of cGMP, quality and safety norms and requirements. Excellent customer service skills and professional demeanor at all times to interface effectively with all internal and external customers
• strong working familiarity with FDA, ICH, EPA, DEP, OSHA, RMP, PSM, and DHS regulations, and experience dealing with outside regulatory and community agencies and employment law
• Experience in audit management at plant Excellent verbal and written communication skills
• Energetic, enthusiastic and motivational disposition
• Maintain confidentiality
• Coaching skills

Education/Experience

• BS or MS in Chemical Engineering desired, but other Engineering degree considered, MBA preferred
• Minimum 20 years’ experience working in a chemical or API manufacturing environment
• Minimum 7 years’ experience in progressive managerial assignments
• Several years of working in an FDA regulated environment
• Understanding of OpEx tools such as Six Sigma, Kaizen, TPM, TQM etc.
• Understanding of CAPEX & OPEX preparation & utilization
• Excellent organizational skills, and ability to drive change and continuous improvement, including Lean manufacturing experience and training skills