Senior Manager, Quality Systems

New Haven, CT | Work from home flexibility

Job Description

Position: Senior Manager, Quality Systems
Location: New Haven, CT – Hybrid Onsite (3 days/week)
Job Type: Contract
Duration: 12 months

Job Description
The client unit is looking for a Senior Manager, Quality Systems to join our team. The department partners with internal stakeholders across Distribution, Operations, Quality, Product Development and Clinical Supply and IT to deliver an effective & compliant quality system for drugs and devices. In this role, the successful candidate will provide high quality end user support and support diverse quality systems initiatives with the objectives of evolving the client’s global quality management system and empowering our business partners to leverage quality as a strategic enabler.

You will be responsible for:

• Use deep process knowledge and experience to assist global business partners with the creation, review, approval, closure and monitoring of internal and external QMS records (for example, deviations, CAPAs, change controls and laboratory investigations). 
• Provide tactical and operational support to the Global Quality Systems Business Process Owner, including but not limited to, stakeholder management, process improvement execution, communication, technical writing and learning program development.
• Sustain and improve QMS compliance through implementation of value-added Quality Management System (QMS) improvements in collaboration with global stakeholders to achieve the client's strategic Quality priorities.
• Develop and deliver quality systems training.
• Create and update procedural documentation and work instructions with accuracy and clarity.
• Support implementation of quality improvement initiatives and integration activities.
• Identify, assess, communicate, manage, and mitigate quality system risks.
• Evaluate new or revised regulations for compliance gaps and support remediation efforts for gap closure.
• Represent CQSC function on business development and integration projects.
• Support GxP audits and inspections.
• Creates and environment supportive of the client’s Quality Culture and Values.
• You will need to have:
• 10 years’ + experience in Quality Assurance within the pharmaceutical industry.
• 3+ years’ experience with Good Distribition Practices compliant Commercial Operations, Supply Chain and/or Product Distribution activities within the pharmaceutical industry.
• Bachelor’s degree in a technical or life sciences discipline (ex. Chemistry, Biology, Biotechnology)
• Able to plan, prioritize and manage workload and manage shifting priorities to ensure commitments are met.
• Knowledge of global GxP requirements for quality systems, drugs, and devices.
• Direct prior experience with planning, ownership, and quality oversight of quality systems records.
• Excellent written and verbal skills and strong interpersonal skills
• Experience managing global projects with team members in multiple time zones.
• The duties of this role are generally conducted in an office environment.  As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.

We would prefer for you to have:

• Lean Green Belt or Black Belt certification preferred.
• ASQ Auditor certification or equivalent certification/experience.
• Knowledge of Veeva Vault Quality and Microsoft PowerBI.

#LI-Hybrid

Queen Consulting Group is an equal opportunity employer. Our goal is to promote an environment that helps our employees and clients appreciate the benefits that diversity provides.

Meet Your Recruiter

Tiffany Louie
Client Delivery Manager

Tiffany is the Client Delivery Manager for Queen Consulting Group, after joining QCG in 2012 as a Technical Recruiter.  Tiffany earned her bachelor’s degree from Boston University.

Tiffany loves to travel, has a golden retriever named Bennie (in honor of the song “Bennie and the Jets”), and she currently lives in Brookline, MA.

• (617) 723-5507
• tiffany.louie@queencg.com
• Connect on LinkedIn