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Randstad Senior Manager - Quality Assurance in Milford, Massachusetts

Senior Manager - Quality Assurance

job details:

  • location:Milford, MA

  • salary:$150,000 - $160,000 per year

  • date posted:Thursday, March 26, 2020

  • experience:5 Years

  • job type:Permanent

  • industry:Professional, Scientific, and Technical Services

  • reference:31629

job description

Senior Manager - Quality Assurance

job summary:

Manage the coordination of activities related to Quality Compliance such as regulatory, internal and client inspections, annual product reviews and supplier quality

location: Milford, Massachusetts

job type: Permanent

salary: $150,000 - 160,000 per year

work hours: 9 to 5

education: Bachelors

responsibilities:

  • Manage and support quality systems which include the following:

  • Inspection Readiness Activities

  • Annual Product Quality Reviews

  • Site Master File

  • Drug Master File

  • Supplier Quality qualification

  • Internal Audit program

  • Deliver user training for the quality systems.

  • Collaboration with other sites on global policies and procedures

  • Regulatory Inspections:

  • Manage the inspection support process for timely delivery of documents, subject matter experts, and information into the inspections room

  • Interface with regulators and represent the company during regulatory inspections

  • Coordinate and collaborate responses to regulatory observations with Subject Matter

  • Update excel tracking spreadsheet for accountable deliverables

  • Update Operation Management Team boards for owner visibility

  • Deliver training for inspection participants

  • ? Support the following

  • Incident Escalation Council

  • Biologic Product Deviation Reports

  • Field Corrective Actions (FCAs)

  • Knowledge sharing through global communications.

  • Ensure compliance with all regulatory standards, systems, procedures and practices including cGMPs and other regulatory requirements as it relates to Quality Assurance activities in the manufacturing facility.

qualifications:

  • BS in science/ engineering or equivalent

  • Minimum of 5 years' experience in Quality, Manufacturing, and Engineering or related field which should include 1-2 years of supervisory experience

  • Must have experience in interacting with regulatory authorities and excellent working knowledge of GMPs, including interpretation and application of regulations across pharmaceuticals and biologics

  • Previous CMO experience is a plus

  • Strong analytical and problem-solving skills

  • Must be a team player

  • Good interpersonal, communication, influencing, and negotiation skills

  • Good project manager skills

skills: GMP (Good Manufacturing Practice)

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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