Site Quality Head (Pharmaceutical)

Posted Yesterday
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Hiring Remotely in California, USA
Remote
Expert/Leader
Information Technology • Professional Services • Biotech • Pharmaceutical
The Role
Lead facility engineering, construction project management, HSE and environmental compliance across pharmaceutical sites. Ensure GMP metrology, maintenance harmonization, emergency response, permitting, budgets, performance metrics, and staff development to maintain compliant, safe cleanroom and warehouse operations.
Summary Generated by Built In

Job Purpose:  

Accountable for facility design and renovation, construction project management and the harmonization of facility engineering systems and maintenance and Health, Safety and Environmental procedures and practice to assure proper office accommodation, cleanroom manufacturing space, warehousing and a safe work environment in compliance with all state, federal, and regulatory governing agencies

Responsibilities:

  • Construction project management for facility design/renovation performed on time and on budget.
  • Engineering consultation on new facility projects at all sites.
  • Environmental permitting at all sites up to date and current as required by state and federal authorities
  • Safety program that meets OSHA and state requirements to assure a safe work environment for all employees.
  • Harmonized facility maintenance procedures and practices to cover critical systems such as HVAC, sanitization, security, safety program, metrology, preventative/predictive maintenance program, contract services, environmental permitting, critical facility documentation, space planning, facility asset management (excluding IT related assets), building and maintenance monitoring systems in compliance with local and federal regulatory authorities such as: OSHA, state permits, FDA, EMA, etc.
  • Continuous improvement program to review opportunities to assure that facility maintenance, safety and environmental related systems and procedures across all sites run in an efficient, cost effective and compliant manner.
  • GMP compliant metrology process for all equipment and instrumentation.
  • As built drawings and process flow diagrams – maintained in an up to date status and readily retrievable
  • Performance metrics for Facility and HSE systems/programs
  • Emergency response plan
  • A safe work environment for department employees.
  • Annual proposed expense and capital budget for the Engineering/HSE department.
  • Department staff compliance with corporate and site specific HR, safety and business policies and practice.
  • Job specific curriculum for the training and professional development of department staff.

Education Level: bachelors in engineering

  • Strong project management and organizational skills.
  • Expert computer applications skills (Excel, Word, Visio, and PP).
  • Excellent team facilitation skills.
  • Excellent documented leadership skills.  
  • Excellent written and oral communication and presentation skills with the ability to speak and communicate effectively with both senior management and front-line staff personnel.
  • Ability to assign priorities in a fast-paced and changing environment.
  • Experience Years: 10 Years related experience and/or training

 



Skills Required

  • Bachelor's degree in Engineering
  • 10 years related experience and/or training
  • Construction project management for facility design/renovation
  • Expert computer applications skills (Excel, Word, Visio, PowerPoint)
  • GMP compliant metrology process knowledge for equipment and instrumentation
  • Knowledge of HSE programs meeting OSHA and state requirements
  • Experience with environmental permitting and regulatory compliance (state/federal)
  • Experience harmonizing facility maintenance procedures for critical systems (HVAC, sanitization, security)
  • Ability to develop training curriculum and professional development for department staff
  • Excellent leadership, team facilitation, written and oral communication skills
  • Ability to produce annual expense and capital budgets for Engineering/HSE
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The Company
0 Employees

What We Do

KMR Search Group is an executive search and recruitment firm specializing in the Healthcare, Pharmaceutical, Biotech, and IT Services industries. Operating with a nationwide reach, they help companies identify and place top-tier leadership talent in specialized roles, as seen in their history of conducting high-level searches for positions such as General Managers and Chief Financial Officers across various industrial sectors.

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