Senior Manager, Quality Systems
ON-SITE 3 DAYS A WEEK
3-month contract to hire or PERM potential
We are hiring a Senior Manager, Quality Systems. Reporting to the Director of Quality Assurance, this position will contribute to the implementation and management of quality systems and will manage QA Document, Training and Record management programs.
- Lead QA function to ensure compliance of the overall Quality Management System and drive continuous improvement.
- Implement and sustain the Quality Management system - eQMS in line with the required regulatory and industry standards.
- Lead the eQMS implementation project and perform routine department activities - Document Control, Record and Training Management.
- Serve as System Administrator for the eQMS - Experienced in Sparta (TrackWise) is a plus.
- Lead and manage training management programs.
- Implement and maintain programs and processes to ensure compliance with current Good Manufacturing Practices (cGMPs) and Good Laboratory Practices (GLPs)
- Author, review and revise Standard Operating Procedures (SOPs) as needed to support the cGMP Technical Operation and regulatory requirements.
- Lead the Quality System Management functions to ensure alignment with manufacturing and servicing operations, support the lean efforts and drive quality improvement for products and services.
- Provide quality viewpoints, opinions on future product and service development.
- Establish and publish the QMS KPIs report for department managers and management review meetings.
- Support internal/external and regulatory inspections.
- Serve as the Quality representative in cross-functional areas to support QA Doc. Control and Training management.
- Establish work priorities to meet targets and timelines and effectively manage completing priorities with minimal supervision.
- Participate in site quality improvement projects in the role of contributor, coordinator, or lead.
- Provide team coaching and mentorship.
- Undergraduate degree in the life sciences or engineering and at least eight years of Biotech industry experience implementing and maintaining electronic quality management systems
- Leadership experience in industry QA Document Control, Record Management and Training Management processes
- Excellent analytical and problem-solving skills with keen attention to detail
- Strong knowledge of FDA guidelines and regulations regarding cGMPs, and advanced proficiency in eQMS, Microsoft office, Google Docs
- Strong interpersonal, written, and oral communication skills
- A solution and team-oriented mindset, the ability to manage multiple priorities simultaneously, and a drive to make an impact.
The anticipated salary range for this role is $150k-180k or $80-90/hour on a contract basis. We encourage candidates of all levels to apply as there may be flexibility on final job title and responsibilities. The salary offer will be based on a variety of factors, including experience, qualifications, internal equity etc. Please note that individual total compensation for this position will be determined at the Company's sole discretion and may vary based on location, skill level, years and depth of relevant experience, and education.