Quality Assurance

  • location: Cambridge, MA
  • type: Contract
  • salary: $90 - $107.80 per hour

job description

Quality Assurance

Job Title: Quality Systems Manager I

Position Description

  • Responsible for quality management systems and processes, to support GXP operations at the Oncology & Biologics (TBOS) organization and its applicable alliance partners and suppliers.
  • Serves as a primary TBOS quality systems representative for global quality management system processes, which include: CMC Change Control and Post Market Commitments, and Annual Product Review/Product Quality Review (APQR) for TBOS commercially marketed products.
  • Supports the strategic compliance direction for critical quality management system processes, including validation, and data integrity.
  • Support implementation and roll-out of the global company electronic quality management systems workflows.
  • Monitors/ensures that site specific quality system workflows remain in compliance and that performance metrics are reported per procedural, company and/or regulatory requirements.
  • Provides expertise and guidance in interpreting governmental regulations, agency guidelines and internal policies related to quality systems, and support and/or represent the Quality Systems functional area as a subject matter expert (SME).

Position Responsibilities

Lead the CMC Change Control and APQR systems for the company.

This position is focused primarily on facilitating the CMC Change Control and Annual Product Review/Product Quality Review (APQR) systems and for providing Quality Systems support for Commercial GMP Oncology and Biologics pharmaceutical operations related activities for which TBOS is responsible. This individual works cross-functionally in a virtual setting, interacting routinely with other company sites and Alliance Partners to ensure global compliance, consistency and efficiency.

This individual:

  • Supports Commercial CMC Change Control Review Board meetings for the seven or more Commercial products for which TBOS either has quality responsibility for or is the Market Authorization Holder.
  • Serves as Change Control Coordinator for two global Commercial products
  • Monitors and completes change controls related to Quality topics.
  • Initiates, revises, and reviews controlled cGMP documents including Procedures and reports.
  • May execute and/or reviews Quality System-related validation test scripts and documents.
  • Supports creation of training materials on department specific procedures and systems.
  • Collects data, calculates, and reports on departmental and site performance metrics.
  • Interacts with management, peers, subordinates and externally, to assess and improve the adequacy of the quality management system processes and procedures.
  • Assures quality and compliance of department work product.
  • Maintains knowledge of current applicable global regulatory requirements.
  • Applies knowledge of cGMPs on a daily basis.
  • Manages day-to-day operations independently.
  • Presents viable alternatives within problem resolution and assists to ensure risk mitigation.
  • Routinely partners with senior management on critical issues.

Staff Management

  • Responsible for mentoring/coaching/training of staff both at site and externally.
  • Determines or ensures proper sequencing of project activities, such that activities are conducted in a timely and efficient manner, project milestones are met, and compliance is maintained.
  • Meets with individual employees and/or groups, both on site and or remotely on a regular basis to discuss, prioritize, and assign work and projects.
  • Meets with functional group on a regular basis to discuss routine activities, individual projects and departmental goals.
  • Develops and maintains strong internal relationships both within the Quality organization and cross-functionally.

Position Requirements

  • Minimum BA/BS with 6+ years or Masters Degree in any Life Sciences discipline with 4+ years relevant experience.
  • Must have previous industry experience in a regulated environment, preferably a broad-based Quality and Regulatory background.
  • Must have Commercial Change Control experience, preferably with global products.
  • Must have direct experience with Quality Systems within the Life Science industry.
  • Must be able to communicate effectively with employees, peers and management.
  • Must be able to read, write and converse in English.
  • Must be experienced in Microsoft Office applications, especially Word, Excel and PowerPoint.
  • Experience with CatsWeb or TrackWise applications desired, but not required.
  • Ability to handle multiple tasks concurrently, and in a timely fashion.
  • Strong interpersonal skills and must be able to work effectively and efficiently in a team environment.
  • Must display eagerness to learn and continuously improve.
  • Must have the following personal attributes: integrity and trust, work ethic, sound judgment, intellectual honesty, pragmatism, courage and conviction.
  • Positive work attitude that supports teamwork and continuous improvement.

Benefits

  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance

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