Germer International - Pharmaceutical Recruiting provided pay range
This range is provided by Germer International - Pharmaceutical Recruiting. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range
$240,000.00/yr - $260,000.00/yr
Direct message the job poster from Germer International - Pharmaceutical Recruiting
Manager of Recruiting & Project Management at Germer International
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
Seniority level
Director
Employment type
Full-time
Job function
Manufacturing, Management, and Strategy/Planning
Industries
Pharmaceutical Manufacturing
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