Job title: QC Director
Job type: Permanent
Emp type: Full-time
Industry: Pharmaceuticals
Expertise: Chemical / Material Healthcare / Medical Pharmaceutical / CRO / Reagents / Personal Care
Location: Allendale, NJ
Job published: 04/29/2020
Job ID: 32663
Contact name: Verónica Lituma, Alex George, Jay Bitas
Phone number: 17865746563, 561-220-3244, 561-712-0307
Contact email: veronica@aprecruiters.com, Alex@APrecruiters.com, Jay@APrecruiters.com

Job Description

QC Director

Allendale, NJ

 

COVID-19 Related Update:

Interviews will be conducted via video calls:

Candidates will conduct interviews online. 

Potential for new employees starting remotely:

If hired, employees will initially receive training remotely and may be able to temporarily start working remotely from home for select roles, until the COVID-19 situation is resolved.

 

Qualifications

  • Bachelor of Science in biological sciences or other relevant field of study. Advanced degree preferred.
  • Minimum of 15 years of relevant experience of which at least 5-10 years in a Management role overseeing a laboratory environment with applicable clinical or commercial experience. Experience with environmental monitoring and aseptic processing is preferred.
  • Knowledge of FDA and EMEA regulations and a working knowledge of root cause analysis.
  • Understanding of quality system applications, including the training, deviations, CAPA management, etc.
  • Experience in authoring, reviewing, and /or approving cGMP related documents (investigation, validation/qualification reports, SOPs etc.)
  • Experience in organizing and leading teams.
  • Experience participating in health authority inspections and/or client audits.
  • Understand requirements pertaining to aseptic manufacture of cellular products.
  • Strong understanding of Tech Transfer and Method Validation
  • Ability to work effectively with clients in a contract manufacturing environment.
  • Familiarity with the product development process for biological products is helpful.
  • Ability to recruit, lead and develop a high-performance manufacturing organization.
  • Capable to communicate in English
  • Strong written and oral communication skills

 

Minimum Required Training (optional)

Working Environment

 

  • Must be able adaptable, collaborative, accountable, and have a “can-do” pioneering spirit.
  • Must be able to foster and work in a team-oriented environment.
  • Must be able to work infrequently on weekends, nights, and/or holidays as required/necessary.
  • May be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids.
  • Small breakroom available. No on-site cafeteria available.
  • The job requires communication with the site leadership during and after working hours as well as working with challenging clients, contractors and advisory personnel.

 

Questionnaire

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