Quality Assurance Manager

Full Time

Gaithersburg, Maryland, United States (This job is on-site)

Job description

Scismic is supporting the growth of a biotech company in Gaithersburg, MD!

We are seeking a Quality Assurance Manager to join the team. The role, reporting to the management team, will provide expert Quality Management System (QMS) guidance to build the company first QMS and ensure that product life cycle remains in compliance with global regulatory requirements and company procedures.

Essential Functions
  • Build up a QMS and ensuring the administration and maintenance requirements of company's QMS are achieved in an efficient and effective manner.
  • Act as a point of escalation for quality issues as they arise internally and at the Contract Development Manufacturing Organization.
  • Maintain GXP standards.
  • Prepare, analyze, and present metrics and quality management review data to drive action and business value.
  • Plan, conduct and complete reports for Internal and Supplier Audits. Reports include objective evidence that audited areas meets the company's and applicable regulatory requirements.
  • Review and authorize quality records. Authorized to approve final disposition of product.
  • Review and manage deviations from contractors/CDMO related to manufacturing and testing.
  • Establish and maintain a system to ensure adherence to applicable regulatory requirements as they pertain to the company. 
  • Own the document control process regarding new or existing documents and other related records, and tracking the status of documents during their life cycle: draft, peer review, approved, effective, retired/obsolete, etc.
  • Management and development of potential direct reports.

Requirements
  • A Bachelor of Science or higher in a scientific discipline is required.
  • A minimum of 8+ years of GMP quality assurance experience in biopharmaceutical/ biotech industry is required.
  • Demonstrate a solid understanding of biopharmaceutical manufacturing – process, analytical operations, quality systems and regulations.
  • Direct experience with document management, SOP development and batch record review is required.
  • Ability to build strong collaborative relationships with partners in and outside of the organization.
  • Strong sense of urgency.
  • Excellent communication and interpersonal skills for effective interaction with internal and external stakeholders at all levels.
  • Ability to manage competing priorities and timelines in a fast-paced environment.
  • Excellent problem-solver with the ability to work independently.
  • Experience with providing direct oversight and support to CMC operation is highly preferred.
  • Experience performing Quality audits is a plus.

What we Offer
  • Competitive Salary and company stock option after 12 month tenure
  • Medical/Rx, Vision and Dental Plan.
  • Short Term and Long Term Disability Benefit
  • Life Insurance and AD&D
  • 401(k) Savings Plan
  • Employee Assistance Program
  • Paid Vacation and Sick Leaves

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