QC Inspection Readiness Lead

$93,500 - $155,900/Yr

Pfizer - Sanford, NC

Full-time - Mid Level

Sanford, NC

5,001-10,000 employees

Chemical Manufacturing

About the position

The QC Inspection Readiness Lead plays a crucial role in ensuring compliance with cGMP regulations and Pfizer Quality Standards within the Quality Operations department. This position involves leading inspection readiness activities, coordinating audits, and implementing continuous improvement initiatives to maintain high-quality standards in commercial and clinical product testing. The role requires collaboration with QC laboratories and involves project management, regulatory compliance, and effective communication to support the delivery of safe and effective products to patients.

Responsibilities

• Lead QC laboratory inspection readiness (IR) walkthroughs
• Coordinate QC IR activities and SME training with Site Inspection Readiness Lead
• Lead network gap assessments for inspection findings and trends for quality control laboratories
• Monitor emerging regulatory expectations and compliance education
• Assist in response coordination for regulatory inspections and corporate audits/assessments
• Plan and execute complex projects; suggest improvement and conduct continuous improvement activities
• Assist QC departments with improvement projects as they relate to inspection readiness
• Assist with inspections/audits
• Perform other QC Lab Compliance functions as needed for business continuity
• Remain up to date on current Regulatory trends (Regulatory Observations, New Regulations/Guidelines)

Requirements

• High School Diploma (or Equivalent) and 10 years of relevant experience OR an associates degree with 8 years of experience OR a bachelor's with at least 5 years of experience OR Master's Degree with more than 3 years of experience, OR a PhD with 0+ years of experience
• Laboratory experience in the pharmaceutical industry
• Excellent project management skills
• Experience driving critical projects to completion within agreed upon timelines
• Excellent oral, written and interpersonal communication skills

Nice-to-haves

• Master's degree and relevant pharmaceutical experience
• Experience in regulatory inspections
• Experience leading continuous improvement projects and knowledge of lean manufacturing, six sigma methodologies and statistics

Benefits

• 401(k) matching
• Dental insurance
• Health insurance
• Paid holidays
• Parental leave
• Referral program
• Relocation assistance