Quality Assurance Manager
Gaithersburg, Maryland, United States (This job is on-site)
- 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.
- 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.
- 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