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Title: Quality Manager - Compliance
Hiring Organization: Connexion Systems & Engineering
Compensation, Benefits, and Employment Type
- Duration – Contract – 6-8 months+
- Pay rate: $72/hr.
- Job Location: Boston, MA
- Job# bh12465
Quality Manager- Compliance
Location: Remote- would like to see candidates local to Boston
- Manage Inspection Readiness Plans
- Would like to see pharma experience
- Expertise with GMP/GDP regulations and application to Manufacturing and Testing risk management principles
- Audit process Root Cause Analysis tools/methodology
- Familiarity with electronic document management systems- QDoccs, Veeva)
General position summary: The Quality Manager – Compliance is responsible for managing real time inspection readiness activities within GMP Operational Quality. Will utilize their technical expertise to optimize interdisciplinary understanding and synergy with the group and integrate activities with other departments to shape a cohesive environment. The Quality Manager is recognized as an expert in the principles and application of quality assurance and compliance.
This position reports to the Associate Director, GMP Operational Quality.
The position is responsible to ensure the successful execution, but is not limited to the following:
- Real-time Inspection Readiness
- Manage Inspection Readiness Plans associated with regulatory filings
- Work with internal teams on key issues to ensure inspection readiness
- Understand timelines and interdependencies
- Assist with developing and providing oversight of mitigation plans
- Communicate risks
- Utilization of tools to ensure efficiency in execution
- Assist in maintenance of opening presentation, Site Master File, SME list and storyboards
- Management of vendor certificates and declarations to support GMP activities
- Work with regional regulatory representatives to understand renewal schedule
- Request required documentation from CMOs / internal team
- Assist with Quality Management Review
- Maintain QLT documentation and action items
- Master’s degree and 3 – 4 years of relevant work experience, or Bachelor’s degree in a scientific or allied health field and 8+ years of relevant work experience, or relevant comparable background
- Proficient at creating tools and processes for efficient execution
- Experience with electronic document management systems (e.g., QDoccs, Veeva)
- Proficient communication skills to facilitate successful cross functional collaboration
- Project Management Skills
- Ability to:
- Drive results
- take ownership and accountability for shared information
- understand technical processes
- Organizational skills
- Critical, Analytical and Strategic thinking- Ability to assess impact across multiple procedures and systems
- Influence and Negotiation skills
- Problem Solving
- Continuous Process Improvement Skills
- Relationship management/conflict management skills
- Knowledge and application of:
- GMP/GDP regulations and application to Manufacturing and Testing risk management principles
- Root Cause Analysis tools/methodology and CAPA
- Audit process
- Operational QA experience in analytical or manufacturing setting with experience with the following is preferred:
- inspection support roles
- Quality System background
- Interpretation and application of GMPs and applicable guidelines/guidance’s (e.g., ICH, USP, etc.) or other industry best practices (e.g., ISPE, WHO, etc.)
Experience with small molecules. Experience with biologics, devices, gene therapy a plus.
Please use the apply button to submit your resume for consideration. A Connexion Representative will contact you immediately.
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