Biotech Partners | Biotech Executive Search

Biotech Partners finds the talent that finds the cure.

Quality Assurance Manager

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  • Date Posted May 18, 2020
  • Location Cleveland, Ohio
  • Job Type Direct Hire
  • Job ID 2113

We are working with an industry leading CRO who is looking for an experienced professional to join them in a collaborative approach on the journey of getting new drugs to market.

Our client is seeking a Quality Assurance Manager in Cleveland, Ohio!

Our client is a CRO that uses the latest technology to provide chemistry, biology, and pharmacology services that support clients from the earliest stages of hit identification all the way through to IND. They hold an excellent employee-retention rate and offer competitive salaries and bonus structures. This position allows for upward mobility in the future, provides regular training and promotes a teamwork-driven environment. This position will develop, manufacture and characterize small molecule drug substances while complying with GLP/GMP regulations. The manager will provide oversight for the company’s quality standards and systems, making improvements when appropriate.

Specific Responsibilities:

  • Review/Approve quality documentation (batch records, project protocols, validation plans, quality agreements and associated analytical data)
  • Responsible for reviewing/approving deviations, the post-investigative report and the corrective/preventative actions to implement going forward
  • Conduct regular audits to ensure all compliance and standards are met
  • Responsible for enforcing Good Manufacturing Practices (GMP) and supplier/material qualification
  • Manage study data related to the company’s quality standards
  • Monitor change control, deviations, and CAPAs through the QMS database
  • Responsible for three to five direct reports
  • Responsible for archives, document control and implementing a training program
  • Manage inspections by regulatory governing bodies (FDA/EMA)

Qualifications:

  • BS in a technical field or a minimum of 7-10 years of experience of in the pharmaceutical/ biotech industry
  • Five or more years in QA manufacturing and small molecule characterization
  • Knowledge of drug development process
  • Familiarity with data integrity and qualifying equipment
  • Experience managing multiple priorities and quality assurance staff

Qualified Candidates, Please Send us your CV

Biotech Partners is one of the leading Life Sciences recruiting companies throughout the United States, placing qualified candidates with world-renowned organizations for over twelve years. Our recruiting consultants are experts in their markets and provide industry insights and interview coaching to their candidates throughout the engagement process.

Pre-Clinical Quality Manager – GLP and Non GXP

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  • Date Posted March 11, 2020
  • Job Type Contract
  • Job ID 2062

We are working with an industry leading Healthcare Company who is looking for an experienced professional to join them in a collaborative approach on the journey of getting new drugs to market.

Our client is seeking a Pre-Clinical Quality Assurance Manager near Boston, MA!

Our client is an industry leading international Pharmaceutical Company that manufactures drugs to treat/prevent a range of diseases and conditions. Innovation is a key element which has helped with tremendous breakthroughs with sickle cell disease as well as cancer. The client has sold their products in over 150 different countries across the world.

Specific Responsibilities:

This position will support the Quality Operations and External Service Quality Team in the review of pre-clinical scientific studies. The Pre-clinical Quality Manager will be responsible for assessing the data integrity and good scientific principles of select externally conducted studies (GLP and non-regulated). In addition, they will support external audit/site visit activity, develop new processes related to post merger as well as acquisition integration activity.  

  • Must have experience with GLP and non-GxP clinical studies
  • Review clinical data of external studies and assess the good scientific principals
  • Conduct vendor audits as well as study reviews on a regular basis
  • Analyze the endpoint movement of biomarkers to uphold quality standards
  • Provide input to documentation and data storage systems
  • Review and maintain up-to-date Standard Operating Procedures (SOP’s)
  • Effectively report any quality issues to the supervisor/maintain GLP schedule
  • Maintain appropriately detailed notes, audit reports and records

Qualifications:

  • Bachelor’s/Master’s degree in science, analytical field or pharmaceutical industry
  • Minimum of three years in the pharmaceutical industry
  • Must have research experience with an emphasis on Quality Assurance
  • At least three years of experience in “hands-on” research in the life sciences industry
  • The ability to manage multiple projects at the same time while working independently
  • Excellent technical writing skills and the ability to manage data
  • Strong analytical background and fluent in English (oral and written)

Qualified Candidates, Please Send us your CV

Biotech Partners is one of the leading Life Sciences recruiting companies throughout the United States, placing qualified candidates with world-renowned organizations for over twelve years. Our recruiting consultants are experts in their markets and provide industry insights and interview coaching to their candidates throughout the engagement process