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Quality Manager - Boston MA - 14653

Newton , MA 02210

Posted: 03/23/2022 Industry: Scientific and Life Sciences Job Number: 14141

Job Description

Connexion’s mission is to provide "best in class" services to job seekers. We strive to achieve excellence in job placement, staffing, and recruiting services, while treating candidates with the professionalism and respect they deserve.

Title: Quality Manager

Hiring Organization: Connexion Systems & Engineering

Compensation, Benefits, and Employment Type

  • Duration: Temp to Perm
  • Pay rate: $40/hr
  • Job Location: Newton, MA
  • Job#: bh 14141

Quality Manager

GENERAL POSITION SUMMARY:

The Quality Manager is recognized as an expert internally in the principles and application of quality assurance and compliance. The Quality Manager coordinates or executes activities on multiple complex projects and takes a role in the design and execution of new projects. The Quality Manager adapts to new and multiple projects, effectively ensuring alignment with corporate goals and compliance with all regulatory requirements. This position reports to Associate Director.

 

 

KEY RESPONSIBILITIES:

  • As part of the GMP Operational Quality group primarily responsible with providing quality oversight and support to operations at the Drug Product Facility in the following key areas/activities; support of manufacturing operations across all phases of development and commercial, support of analytical laboratory operations, and materials management.

 

Product Release – Internal Manufacturing

  • Responsible for commercial and clinical batch disposition. Review batch data, including batch records, deviations, in-process data, EM data, QC release testing and other quality systems as applicable to determine acceptability of product disposition.
  • Responsible for approval of clinical and commercial lot COAs, generating BSE/TSE statement and product labelling
  • Responsible for archival of batch records and other disposition supporting documents in QDoCCs.
  • Responsible for generating performance metrics, trends; including site metrics for disposition

 

Compliance Oversight of Internal Operations – QA Operations and Compliance

  • Provide production floor support and provide guidance for GMP product quality and compliance for product release, including resolution of product quality investigations and quality issues of a significant nature, and provides direction for product disposition decisions including shipment.
  • Review and approval of Manufacturing documents e.g. MCR, MBR, Recipe, Engineering Parameters etc.
  • Responsible for raw material release, area clearance and equipment release.
  • May be required to assist the QA Engineering group with activities associated with equipment, instrument, utilities, and/or facility qualification activities including change control, and support of site programs.

 

Compliance Oversight of Quality Systems

  • Provide QA support of development and commercial change controls, GMP investigations, associated CAPAs and Effectiveness Checks. Lead the investigation/CAPA triage meetings (as necessary) and collaborate with customer groups to ensure quality systems are monitored and established metrics are met.
  • Responsible for generating performance metrics, trends; including site metrics for investigation/CAPA, etc.
  • Lead compliance walkthroughs of the site and help drive the closure of any observations.
  • Responsible for identifying risks and communicating gaps for GMP process/systems.

 

Quality Process and Ownership of Equipment, Area, and Incoming Material Release

  • Responsible for identifying risks and communicating any gaps for quality processes optimization for area/equipment release, material disposition, quality systems etc.
  • Participate in continuous improvements of department processes, realizing efficiency gains, and ensuring team continues to meet expanding business needs with lean resources.

 

Establishing or Tech Transfer of Products

  • Responsible for supporting new product introduction into the Drug Product Facility by review and approval of new MBRs and material master files.

 

Audit / Inspection Support

  • Participate in inspection readiness activities and provide support during regulatory site inspections.

 

Deployment of QMS and Establishment of Compliance Expectations

  • Participate in process improvement initiatives (as necessary), performing gap analysis and risk communication.
  • Act as a trusted advisor to the site by providing compliance guidance through collaborative review and working with the business owners to gain a better understanding of their needs and facilitate resolution of quality issue in a timely manner.

 

Individual Development and Training

  • Responsible for timely completion of trainings (100% on time), goal development, self-evaluation and IDP

 

MINIMUM QUALIFICATIONS:

  • Demonstrated success independently leading cross-functional teams
  • Experience providing QA support and oversight of GMP manufacturing operation including batch release
  • Experience with drug product (oral solid dosage forms preferred) development and manufacturing with proficient knowledge of the following in a pharmaceutical setting:
    • cGMP’s and associated CMC regulatory considerations
    • experience with continuous manufacturing a plus
  • Experience with equipment, facilities and utility system qualifications activities in a cGMP setting
  • Experience successfully leading event investigations, Root Cause Analysis (RCA), and CAPA
  • Experience with network based applications such as VeeQMS, Oracle and TrackWise preferred.
  • M.S (or equivalent degree) and 3+ years of relevant work experience, or
  • B.S in scientific or allied health field (or equivalent degree) and 5+years of relevant work experience

 

 

 

Please use the apply button to submit your resume for consideration. A Connexion Representative will contact you immediately.

 

When responding to this job posting you MUST include the Job# and Job Title in your subject line.

 

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Meet Your Recruiter

Alexandra (Scuncio) Pettit
Team Lead, Sr. Technical Recruiter

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