Head of Operations - Site Leader

Head of Operations - Site Leader

Our client is a global leader in the development and manufacturing of generic injectables for the hospital market. This is a mature well established site which is a key and consistent source of revenue for the parent company.

Do you thrive and enjoy the pace of having ownership of a 24/7 plant? Do you enjoy working in a manufacturing environment with the chance to make a difference with all levels in an organization from operators to managers to vice president levels and above? Guess, what? You would be an excellent fit in this role.

This site is at a crossroads with the potential to be taken to the next level with the right leader who can bring with them a history of cutting costs and improving efficiencies at all levels and across all departments.

The best part about this company is it's people and it's can-do culture and how can we improve culture. Always looking to collaborate in order to make an impact in order to provide a better product for it's end user patients

Head of Operations - Site Leader - 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 15 years’ experience working in a chemical or API manufacturing environment
• Minimum 5 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