Sr. Quality Manager

Boston, MA
Feb 16, 2018
Required Education
Bachelors Degree
Position Type
Full time

Job Description

Client is committed to the highest standards of safety, performance and regulatory compliance for bringing new products to the market.  To achieve this commitment, the Sr. Quality Manager is responsible for providing oversight, guidance and ownership for the GxP Document Control Processes and their associated electronic systems.. The Sr. Quality Manager monitors the processes to ensure efficient operation while maintaining compliance with global regulatory requirements.  The Sr. Quality Manager works closely with key business partners to continuously improve their processes as well as to evaluate and address any gaps or risks that may arise.

This position reports directly to the Associate Director, Quality Systems.

Key Responsibilities:

  • The responsibilities of this position may include, but are not limited to, the following:
  • Serve as Process Owner for GxP Document Control Processes:
  • Define and optimize work processes and  serve as Document Owner and SME
  • Ensure process is current and meets requirements of global regulations
  • Identify and analyze process related metrics- monitor process related metrics for efficiency and cost of quality
  • Serve as Training Owner and SME for process
  • Provide strategic guidance for and facilitate ongoing maintenance of processes and supporting system(s)
  • Identify risks/communicate gaps to quality system owners/QLTs
  • Serve as Reviewer/Approver or Owner of deviations to process
  • Monitor and trend events related to process and identify/propose Corrective Actions to address/May serve as CAPA Owner
  • Provide audit and inspection support for process
  • Collaborate with business partners to ensure alignment with business needs
  • Provide strategic direction for electronic system setup and configuration
  • Participate in Business Development Activities as needed
  • Ensure successful process execution and appropriate support
  • Assist in development of process changes and training materials
  • Train and coach users
  • Provide Customer support (troubleshooting, answer questions)
  • Maintain Job Aids and Tools
  • Participate on project teams as needed
  • Monitor adherence to process
  • Perform Electronic System validation activities
  • Serve as People Manager for one or more staff:
  • Provide functional area leadership and management of Team through the execution of the following:
    • Workforce Planning/ Resource Modeling
    • Performance Management (goals, monitoring, reviews)
    • Employee Learning and Development (Identification of training needs and support of aspirational goals via IDP)
    • Talent Acquisition/ Recruiting/Interviewing/ selection
    • Onboarding/ Transition/Succession Planning
    • Monitoring /Supporting Employee Engagement
    • Management /Monitoring of Budget
    • Oversight of day to day execution
    • Communication of expectations
    • Participation in QA Business Reviews
    • Providing strategic oversight of function
    • Defining functional area vision to align with Quality Systems vision
    • Monitoring structure of team/department

Minimum Qualifications

  • Master’s degree and 4-5 years of relevant work experience, or Bachelor’s degree in a scientific or allied health field (or equivalent degree) and 9+ years of relevant work experience, or relevant comparable background

Preferred Qualifications:

  • Ability to "connect the dots" with other impacted processes/systems
  • Ability to articulate vision and inspire action; change agent
  • Ability to coach and develop staff
  • Ability to design, develop and deliver effective training; understands and adapts to varying learning styles
  • Ability to drive results
  • Adaptability/flexibility
  • Change Management
  • Coaching / Influencing/ Communication-listening, providing direct, open/honest feedback
  • Creativity/ Futuristic thinking- utilization of emerging technologies to enhance and support the process
  • Critical thinking/Problem Solving Skills/Decision making
  • Cross-functional Collaboration
  • Growth mindset
  • Operational Excellence- continuous process improvement processes/ tools
  • Project Management- time and resource management and prioritization
  • Relationship Management skills- influence, conflict management,  and ability to understand and translate customer needs
  • Risk based thinking
  • Solid GxP knowledge with Understanding of global regulations governing the process
  • Strategic thinking- forward thinking, planning with ability to map out how to handle global v. local procedures
  • Technical writing