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Director / Associate Director
Quality Operations
Posted on 8/1/2022
INACTIVE
Locations
Everett, MA, USA
Experience Level
Entry
Junior
Mid
Senior
Expert
Desired Skills
Agile
Leadership
Management
Requirements
  • BS/BA with 7+ years experience or MS/MA with 5+ years experience in a GxP QA-related function within a CRO, biotech, medical device, or pharmaceutical company
  • Minimum of 5+ years of management experience
  • Experience with Quality Management Systems (e.g., documentation and record management, change control, deviations, investigations, training, and CAPA programs)
  • In-depth knowledge of and ability to interpret and apply GxPs, EU, FDA, and ICH regulations, guidelines, and industry best practices (e.g., ISPE, DIA, PIC/S) specifically around IT systems and software development
  • Ability to effectively negotiate and build collaboration amongst individuals
  • Demonstrated ability to train, manage, and coach staff
  • Demonstrated ability in leadership roles
  • Excellent interpersonal, verbal, and written communication skills
  • Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities
Responsibilities
  • Develop and coach a growing team of quality professionals
  • Optimize organizational structure to adapt to the fast-growing needs of the business
  • Create QRB metrics to measure performance and identify robust continuous improvement actions
  • Collaborate and influence other functions to deliver on-site and company goals
  • Ensure all product-related deviations, and CAPAs, are initiated, investigated, and resolved
  • Ensure that the corporate training curriculum is right-sized, compliant, monitored and reported
  • Ensure process control measures are in place and followed
  • Works on multiple assignments in collaboration with various department system owners
Desired Qualifications
  • ASQ or CISA certification
  • Exposure to Agile SDLC, SaaS, and/or IT cloud technologies
Veeva Systems

1,001-5,000 employees

Cloud computing services for pharmaceutical companies.
Company Overview
Veep's mission is to help R&D, quality, and regulatory teams eliminate inefficiencies and bring high-quality, safe, sustainable products to market without compromising quality. The company builds cloud-based tools for pharmaceutical research.
Benefits
  • Parental leave
  • PTO
  • Free food
  • Health, dental, & vision insurance
  • Gym membership reimbursement
Company Values
  • Do the Right Thing
  • Customer Success
  • Employee Success
  • Speed