Halo Pharmaceuticals

Quality Control Compliance Manager

US-NJ-Whippany
Type
Regular Full-Time

Overview

The Quality Control Compliance Manager oversees 5 to 7 analytical supervisors responsible for analytical testing, documentation review and Investigations; supports transfer of robust analytical methods to be used for analytical testing and maintains laboratories in a state of GMP readiness. The Manager assigns, supervises and establishes daily work assignments in the QC data review group which includes developing timelines, work plans, and milestones for the direct reports; identifies and/or leads key projects for continual improvement of compliance in laboratories as appropriate.

 

Responsibilities

 

ESSENTIAL FUNCTIONS

  • Manage the activities of supervisory and analytical staff in a GMP QC laboratory testing environment, schedule and assign/prioritize laboratory activities aligned with organizational goals.
  • Support laboratory staffing; provide input on hiring decisions, access to training and manage performance and development of staff.
  • Ensure the laboratory is properly equipped; provide recommendations for instrument acquisition as needed.
  • Represent QC cross-functionally, provide technical subject matter expertise and apply sound scientific judgment based on experience and knowledge of laboratory operations. Participates in internal and external audits.
  • Ensures accountability for thorough, well documented and timely laboratory deviation/investigation reporting
  • Effectively utilize Change Management, develop and execute continuous improvement initiatives within QC.
  • Coach and mentor staff, oversee effective utilization of all quality management systems by laboratory personnel, develop and maintain compliance metrics and report to management
  • Maintain and improve Quality Control GMP compliance and documentation, ensure integrity of QC data for support of regulatory submissions.
  • Follow-up with functional department for timely completion of corrective and preventive actions recommended.
  • Audits and evaluates current policies, procedures, and documentation for compliance with government laws and regulations, as needed
  • Adheres to all applicable procedures, cGMPs, company policies and any other quality or regulatory requirements. (i.e. OSHA, DEA, FDA, MHRA, etc.)
  • Writes and revises SOPs, forms, protocols and other controlled documents.
  • Must be willing to work a flexible schedule to support shift operations. May be required to provide off-shift supervision to department personnel.
  • Performs other duties as assigned.

 

 

 




Qualifications

POSITION QUALIFICATIONS

  • Prior experience working in a cGMP/GLP environment required. 
  • Solid knowledge and proficiency with analytical methods currently used for purity, potency identity, and impurities testing for release and stability of drug product and drug substance. Solid knowledge in interpretation of USP and EP is required.
  • Must possess excellent communication (oral and written), organizational, and interpersonal skills with ability to multitask while working under restrictive timelines.
  • Must be able to work in a team environment and perform job responsibilities under minimal supervision. 
  • Must have familiarity with FDA and ICH guidelines and be able to maintain laboratories in a state of compliance with cGMP guidelines. 
  • Must be proficient with MS Office applications. 
  • Flexibility to work outside of business hours, should issues arise.
  • Ability to recognize what needs to be done, taking action, and accomplishing results as the situation demands.

EDUCATION:

  • Bachelor’s degree in chemistry, biology, or related discipline. 

EXPERIENCE:

  • 7-10 years of experience in a Pharmaceutical environment; or equivalent combination of education and experience. 
  • Must have 7 years of experience working in a GMP Analytical Laboratory.
  • Minimum 5 years of supervisor or management experience within GMP Analytical laboratory.

 


 

 


 

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