Senior Quality Assurance Manager Job at Meet Life Sciences, Redwood City, CA

amhhRDJkSDR1OUNJS0RqNzNicVQ3WGhwT3c9PQ==
  • Meet Life Sciences
  • Redwood City, CA

Job Description

Responsibilities

  • Lead/manage Good Clinical Practice (GCP) audits, including clinical investigative site audits, clinical vendor audits, clinical department internal audits, Trial Master File (TMF) audits, and applicable study document audits, including Clinical Study Reports (CSRs)
  • Serve as a QA representative and support clinical study teams to provide compliance advice
  • Participate in review and approval of clinical study documents and clinical SOPs / Guidance Documents
  • Manage study-specific Clinical Study Audit Plans (CSAP) compliance for the assigned program by using a risk-based approach for clinical studies
  • Review and approve investigational product (IP) temperature excursions to ensure release or rejection of IP on time
  • Lead continuous improvement of the Clinical Quality Management Systems (CQMS) and processes, including creation and revision of SOPs for GCP compliance and excellence
  • Manage and support inspection readiness activities for GCP
  • Support clinical inspections conducted by regulatory agencies, including sponsor inspections, clinical investigative site inspections, and contract research organization (CRO) inspections
  • Support GMP, GLP, and PV inspections
  • Lead clinical non-compliance event investigations and CAPA implementation
  • Perform quality metric analysis for clinical QA including study quality event trends from clinical process deviations / CAPAs to include a review of protocol deviations, safety, and other clinical data
  • Maintain a contemporary knowledge of agency and industry trends, standards, and methodologies as related to GCPs. Maintain the GCP regulatory surveillance program
  • Provide cross-training development opportunities to QA team members, and mentor/coach junior QA team members upon request or as an assigned supervisor

Preferred Education & Experience

  • BA/BS degree in a relevant field, or equivalent experience
  • 6+ years’ clinical research experience
  • Understanding of Quality Systems that support GCP quality activities
  • Experience with advanced Microsoft Office applications (Word, Excel, PowerPoint)
  • Experience developing GCP processes for the best industry practices and training

Job Tags

Contract work, Work at office,

Similar Jobs

St. Anthony Foundation

Substance Use Counselor Job at St. Anthony Foundation

 ...legal, vocational and educational needs, most or all of which have been affected profoundly by the cycles of poverty and addiction. Counselors conduct assessments, one-on-one counseling, educational and group counseling sessions to a caseload of up to 12 residents and... 

Visiting Rehab and Nursing Services

Physical Therapy Assistant - PTA - New Grad Job at Visiting Rehab and Nursing Services

 ...Choose Your Own Schedule: Flexible hours so you can find your rhythm ~ Full-Time Perks: Medical, dental and vision ~ PTO & Paid Holidays: Actual time off to recharge ~401(k) with Match: Because its never too early to think ahead ~ Mileage Reimbursement: $0.62/... 

Schneider Buchel LLP

Supervising Attorney Job at Schneider Buchel LLP

 ...valued, youll feel right at home here. Responsibilities About the Role We are seeking a highly capable and detail-oriented attorney with significant experience in New York landlord tenant matters to serve as the Supervisor of our Landlord Tenant Department. This... 

Graham Automotive

Audi/Volkswagen Automotive Lube Technici... Job at Graham Automotive

Job Description Graham Automotive is seeking a Lube Technician. This is a very fast paced opportunity that requires the ability to multitask at a high level. We consider this a stepping stone to our in-house apprentice technician level. The right individual has some experience...

Onward Search Education

School Adjustment Counselor [80776] Job at Onward Search Education

 ...nation's top schools. We're partnering with an fantastic school district in Franklin County, MA searching for a School Adjustment Counselor to join a dedicated academic team to support high school-aged students. In this role, youll provide targeted social-emotional...