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Sr. Manager Clinical QA

  • Job type: Permanent
  • Location: Woodcliff Lake, New Jersey
  • Salary: Negotiable
  • Job reference: 250911/003_1551135014
  • Sector: Quality Assurance, EPM Scientific
  • Date posted: 25/02/2019

Title: Senior Manager, Clinical QA

Permanent, Full Time

About the company:

This is an exciting, large, fast-paced pharmaceutical company that works in over 25 countries. They work on research, manufacturing, and marketing of prescription drugs in many different therapeutic areas. As a leader in the industry, they are looking for someone can assist the Director of QA and lead and help with QA audits.

The Senior Manager Clinical QA will be responsible for:

  • The Senior Manager will need to conduct clinical site and GCP document audits to address the results of CAPAs and other complaints. Finding various gaps and being able to coordinate with others to ensure remediation for a strong Quality team.

  • Communicate with contract and GCP auditors. This may include meetings with company personnel and auditors, managing Audit Programs, and helping draft audit plans. It also involves working directly with CRO's and maintaining communication for GCP compliance.

  • Assist with quality improvement by improving communication of audit results and of compliance terms as well. This may also include going to several meetings and maintaining quality to internal standards and regulatory requirements.

The Senior Manager Clinical QA should have the following qualifications:

  • BA/BS degree or higher in life/technical sciences

  • 5-8 years pharmaceutical experience

  • In-depth knowledge of GCP and national/international regulatory standards

  • Ability to travel 25%

Benefits:

  • Competitive pay and potential growth opportunities

  • Bonus opportunity and company perks

  • Strong benefits package and a vast network of resources

If you are interested in the Senior Manager role, then apply today!

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