Director, Quality systems Job at Skills Alliance, Waltham, MA

bUpsRVRuMGZMNGRXZXhXdjhmT1Jab2I3S3c9PQ==
  • Skills Alliance
  • Waltham, MA

Job Description

  • Director, Quality Systems
  • Job Type: Permanent
  • Location: Waltham, MA. Site based
  • Salary: Up to $230K + Bonus + Benefits
  • The company is a cutting-edge clinical-stage biotechnology company mainly dedicated to the Nephrology space. They have a dynamic pipeline of groundbreaking therapies.

    As the Director, Quality & Compliance, you will take a leading role in advancing and overseeing the Quality Management System to align with relevant global regulatory standards and company business goals. This position offers significant visibility within the organization.

    Responsibilities

    • Oversee companywide GxP training programs, aligning training requirements with job functions.
    • Lead the development and maintenance of the audit and inspection readiness programs.
    • Contribute to the continuous improvement of the inspection readiness program and new initiatives.
    • Develop, review, and monitor quality agreements and contracts.
    • Manage GxP Training, Supplier Management, and documentation systems.
    • Support the Quality Management Review process by analyzing and reporting on Quality System and supplier performance metrics.
    • Oversee the supplier qualification program, including audit planning and execution.
    • Develop and enhance scalable quality processes to meet organizational growth.
    • Cultivate a quality mindset across the company through risk-based decision-making.
    • Assist in presenting management reviews of quality compliance and operational KPIs to address unfavorable trends promptly.

    Qualifications

    • Minimum 15+ years in Biopharmaceutical Quality or Compliance roles
    • BA/BS Degree in a sciences discipline
    • In-depth knowledge of GxP, Quality Systems, and Compliance for safety, data integrity, and product quality
    • Recent experience managing and influencing stakeholders on GxP topics
    • Experience in leading inspection readiness initiatives
    • Experience with Veeva and ComplianceWire

    Please reach out to David.fearnley@skillsalliance.com or call +1 646 492-5308 for further details.

Job Tags

Permanent employment,

Similar Jobs

Belle Tire

HRIS Analyst (UKG) Job at Belle Tire

 ...JOB SUMMARY: The HRIS Analyst will play a pivotal role in the management of the UKG human resources information system, ensuring its optimal performance and utilization within our organization. This role involves collaborating with cross-functional teams, managing data... 

Shakespeare Company

Director of Finance Job at Shakespeare Company

 ...Director of Finance Columbia, SC (Shakespeare) Job Summary: The Director of Finance is a leadership role responsible for overseeing the organization's financial operations. This individual will lead financial planning, reporting, and analysis, and drive key financial... 

Anaheim Global Medical Center

Registered Nurse, 8 Hour, Per Diem Job at Anaheim Global Medical Center

 ...stay criteria. Formulates discharge plan, interview patients and family members for discharge needs. Collaborates with physicians, nursing and ancillary staff as well as payers. Enters medical reviews into QRS system. Documents appropriate reviews for all patients, Medi... 

Staffing Ninja

Senior Tax Accountant Job at Staffing Ninja

 ...Job Title: Senior Tax Accountant Location: Casper, WY Salary: $90,000 - $100,000 per year Employment Type: Full-time, On-site About the Job: This is an exciting full-time opportunity for a Senior Tax Accountant responsible for managing the complete tax... 

Workpath

Remote Work From Home Part Time Data Entry Job at Workpath

Remote Work From Home Part Time Data Entry / Typing This is your opportunity to begin a lifelong career with endless opportunity...  ...weekly pay Safe workplace Multiple shifts are offered from early morning to night and no experience is needed. You will have ample...