Quality & Regulatory

QC leadership opportunity - build the lab! Direct Hire MA

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Job ID: 15078 Direct Hire MA

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Our client is one of the top gene therapy companies in the Cambridge/Boston area and they are seeking an experienced QC leader (targeting Sr. Manager or Associate Director level) to build the QC lab as they transition the function from completely virtual to in-house.  This is with a mid-size company and they have a company culture that can't be beat.  Don't miss your chance to make a significant impact for patients afflicted with rare diseases and cancer. 

The main function of this role is to lead creation of a new commercial-level in-house GMP testing function. 

Responsibilities include but are not limited to;
•  All aspects of in-house testing for release and stability for multiple portfolio products
•  Development and/or tech transfer of analytical methods, method training, and method trending 
•  Ownership of data integrity/control, sample handling/tracking, and LIMS implementation.  
•  Hiring, training, and staff development for a small group of 3-5 direct reports with potential to grow a larger team in the future.
•  Interacting with regulatory inspectors during inspections and contributing to regulatory filings

Formal descriptions can be supplied for interested candidates. 

Qualified candidates will have BS degree or higher and 10-15+ years of experience in a GMP QC biologics setting.  Preference given to those with experience with build-out and/or bringing new QC labs online.  Ideal candidates will have hands-on experience previously with HPLC, ELISA, bioassay, qPCR, cell culture, and cell banking. Must have strong knowledge of cGMP/ICH/FDA/EU stability regulations.  

Must be authorized to work in the US indefinitely to be considered.  Relocation assistance available for qualified candidates.  All resumes will be kept strictly confidential until you choose to pursue a specific opportunity with one of our clients.

Supplier Quality Lead Direct Hire MA

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Job ID: 15012 Direct Hire MA

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Global Pharmaceutical company here in Lexington, MA Area is seeking a Supplier Quality Management Lead!  This role will be responsible for performing all Supplier Quality Management functions in support of the GMP manufacturing site.  Other responsibilities include but not limited to:

  • SQM liaison / local SQM expert at the manufacturing facility
  • Supplier Qualification (New Supplier Request, Qualification Audits, Quality Agreements)
  • Supplier Notification of Change/Vendor Change Notification
  • Supplier Monitoring and Supplier Issue Resolution Support /SCARs
  • Inspection Support for SQM system and vendor approvals
  • Ensure adherence to domestic and international regulations and company policies/standards
  • Partner routinely with site stakeholders and management to understand priorities, align on expectations and escalate issues in a timely manner
  • Support regulatory inspections and related activities

Requirements:

  • Bachelor's degree with 5+ years of QA experience within the pharmaceutical, biopharmaceutical, medical device, or related industry.
  • Thorough knowledge of applicable regulations and standards
  • Strong Quality Systems experience, including Supplier Quality Management

Preferred:

  • Previous Biologics, Pharmaceutical, Medical Device, or Plasma Quality Operations experience
  • Previous Supplier Quality Management, Receiving and Inspection, and/or Audit experience

GxP Auditor, gene therapy Direct Hire MA

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Job ID: 15004 Direct Hire MA

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Our client is one of the top gene therapy companies in the Cambridge/Boston area and they are seeking an experienced GxP auditor to join their growing Quality Compliance team!  This is a low travel (<25%), in-house, permanent role with an organization whose company culture can't be beat.  Don't miss your chance to make a significant impact for patients afflicted with rare diseases and cancer.  

The main function of this role is to support the integrated audit program (GCP, GMP, GLP, GTP) and the inspection management program.

Responsibilities include but are not limited to;
•  Scheduling, organizing and execution of internal and external audits 
•  Compilation of quality metrics related to audits for dissemination at Quality Council and Management Review.
•  Recommend and implement improvements to the Audit and Inspection Management programs based on new regulations, guidance documents, and industry standards. 
•  Assist in company and site preparations for support of regulatory inspections.

Formal descriptions can be supplied for interested candidates. 

Qualified candidates will have a BS degree or higher, preferably in a scientific discipline.  Must have at least 5+ years in a GMP setting (QA, QC, Manufacturing, Process Development, etc.), preference given to those with both GCP and GMP auditing experience.  Must have knowledge of US and EU GCP, GMP, and GTP regulations as well as ICH Q7, Q8, Q9, Q10 and other international regulatory requirements.     

Must be commutable to the Cambridge area or able to relocate with very limited assistance.  

All resumes will be kept strictly confidential until you choose to pursue a specific opportunity with one of our clients.

SDS Chemical Labeling Associate Direct Hire MA

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Job ID: 14968 Direct Hire MA

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Our Large Biotechnology client, who is a Global Leader in the development and commercialization of assays, immunoglobulins and cutting-edge research tools is hiring!   They are looking to bring onboard a new Chemical Labeling Associate with focus on SDS and GHS content!  This role will focus on driving product compliance with globally harmonized system of classification and labeling of chemicals (GHS).  Responsibilities include but not limited to:

  • Drive a process to ensure detailed product data is provided for the preparation, and management of safety data sheets, including GHS label content
  • Supervise dangerous goods classification and all supporting activities related to release of dangerous goods
  • Coordinate with internal teams to ensure that packaging and labeling requirements are met
  • Support implementation processes to identify and comply with product regulations around the world, including dangerous goods for transportation, chemical notification, registration, and integration of customers’ needs based on requirements
  • Collaborate with a cross-functional team including, but not limited to production, safety, operations, development and shipping regarding procedures for compliance of current, and new products
  • Proactively drive continuous process improvements, and resolution of chemical regulatory issues that may impact the release of new products

Requirements:

  • B.S. in Chemistry, Biology, Occupational Safety & Health, Environmental Engineering, or equivalent technical degree
  • 2-5 years of relevant experience in a global production environment
  • Experience with authoring SDS documents and generating GHS label content
  • Familiarity with regulatory database systems, such as The WERCS

QC Stability/Lab Operations Leader, Biologics Direct Hire MA

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Job ID: 14751 Direct Hire MA

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Our client is one of the top gene therapy companies here in the Cambridge/Boston area and are seeking an experienced QC leader to head up both the QC Stability program as well as QC Lab Operations (laboratory equipment management, sample and reagent management, reference material management).

The main function of this role is strategic management of stability programs for ancillary materials, starting materials and drug products, and to lead a team managing QC laboratory equipment, reagents, sample, information and reference material programs.

Responsibilities include but are not limited to;
•  Build a risk-based stability program in support of their early and late-phase clinical development programs.
•  Originate ICH compliant stability protocols and reports and hands-on leadership of the QC Stability function
•  Trend stability data and establish retest and expiration dates 
•  Collaborate with Quality management and external partners/CTOs to generate, review and approve documentation, including: SOPs, analytical test methods, change controls, deviations, CAPAs and OOS/OOT investigation reports
•  Prepare and review CMC stability sections for clinical regulatory filings, MAA, and BLA

Formal descriptions can be supplied for interested candidates. 

Qualified candidates will have BS or MS degree in a Life Sciences discipline and 10+ years of industry experience in a GMP QC setting.  Must have experience with biologic therapeutics (cell and/or gene therapy products a plus) and strong knowledge of cGMP/ICH/FDA/EU regulations.  Must also have understanding of statistical analysis as it relates to product stability trending and experience with statistical software packages such as JMP.  Experience with LEAN/Six Sigma is highly desirable but not required.  

Must be authorized to work in the US indefinitely to be considered and must be commutable to the Cambridge area.  Relocation assistance available for qualified candidates.    

All resumes will be kept strictly confidential until you choose to pursue a specific opportunity with one of our clients.

QC Manager/Group Leader, Technical Services Direct Hire MA

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Job ID: 14661 Direct Hire MA

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One of the largest and fastest-growing biotechnology companies in the Boston area is actively seeking an experienced Manager/Group Leader to join their QC Technical Services group.  Our client has several approved products on the market
and a robust pipeline of new biologics in development.  This will be based at their campus in the suburbs of Boston/Cambridge at one of the key sites for this global company.  

In this role, you will lead a small team responsible for non-laboratory activities that ensure overall effective QC operations. Additionally, the role supports Quality projects and implementation of operational excellence initiatives. 

Responsibilities include but are not limited to;
• Lab scheduling, metrics reporting, non-routine protocol review, and QC archiving.
• CoA generation and specification management for drug substance and drug product 
• Support inspection preparation activities as well as provide resources for inspection management 
• LIMS builds in support of analytical and/or process development or investigational programs 
• Oversight of storage of retains, reserves, and reference standards for internal programs and specified external programs 
• Monitor QC cold storage capacity and ensure sustainability for storage of an expanding portfolio
• Coaching and development of junior staff.    

Formal descriptions can be supplied for interested candidates. 

Qualified candidates will have BS degree or higher in a life-science or engineering discipline and 10+ years of experience in a cGMP manufacturing or quality environment.  Experience with LIMS or LEAN/Six Sigma methodology a plus but not
required.

Must be authorized to work in the US indefinitely to be considered and must be commutable to the Cambridge area or able to relocate with very limited assistance.  

All resumes will be kept strictly confidential until you choose to pursue a specific opportunity with one of our clients.

Head of Quality Direct Hire MA

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Job ID: 14596 Direct Hire MA

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Quality Assurance leadership opportunity at one of the state's top biopharma campuses, producing commercial and clinical biologics.  This will be part of the Site leadership team and will oversee a team of direct and indirect reports totaling in the range of 120 - 150 staff.

The main function of this role is to lead design and execution of the strategy for compliance to Good Manufacturing and Good Distribution Practices for manufacturing, research, and warehouse operations at a multiple sites in the suburbs of Boston.  

Responsibilities include but are not limited to;
•  QA oversight and compliance of: quality systems (change control, CAPA and deviations); audit support; plant QA operations; internal product technology transfer; and facility compliance. 
•  Responsible for bulk drug substance manufacturing/ testing oversight and final lot disposition for commercial and clinical (DS specific) use. 
•  Responsible for review and approval of site validation activities. 
•  Responsible for Quality Control site testing including raw materials, environmental monitoring, and microbiology and oversight of related investigations.
•  Overall responsibility for cross-plant quality alignment.    
•  Lead and coach direct team and drive a high performance organizational culture that accommodates rapid growth and highly dynamic expectations
•  Responsible for timely updates of site achievements and challenges to management with a focus on quality compliance, operations performance, staff performance and productivity, staff development, continuous improvements, key projects support and identification and resolving obstacles to maintain a highly effective and productive functional group.
•  Ability to lead complex material review boards to determine the ultimate outcome of complex deviations/dispositions which are based on data, science, and compliance
•  Creation and management of the Site Master Files & management of site (plant) licensures

Formal descriptions can be supplied for interested candidates. 

Qualified candidates will have a Degree in technical discipline such as biochemistry, chemistry, engineering and at least 15+ years of experience in the biotechnology and/or pharmaceutical industry with experience leading large Quality teams (50-100+).  Must also have track record of effective Quality leadership for internal production facilities, testing, sampling, and product disposition and experience in providing Quality oversight for engineering and validation projects supporting internal operations and tech transfer activities.  

Must be authorized to work in the US indefinitely to be considered and must be commutable to the Greater Boston area.  Relocation assistance available for qualified candidates.    

All resumes will be kept strictly confidential until you choose to pursue a specific opportunity with one of our clients.