Compliance Specialist / Sr. Compliance Specialist

Job summary
Compliance Specialist at AstraZeneca Pharmaceuticals LP (AZPLP) in Newark, Delaware, United StatesFull-time positionResponsible for managing compliance programs and quality systems
Job seniority: mid-to-senior level
Responsibilities
• Manage all Compliance programs and lead/execute required Compliance activities• Provide oversight/process ownership for core Quality Systems• Drive continuous improvement efforts through monitoring/evaluation of site systems & processes• Host/lead/manage inspections of site by External Customers, internal assessors, and Regulatory authorities
Requirements
• Bachelor's degree in a Science/technical field such as Pharmacy, Biology, Chemistry or Engineering• Minimum of five (5) years' experience in the pharmaceutical industry and/or FDA experience• Strong knowledge of global regulatory and cGMP requirements, industry best-practices• Strong familiarity with production operations• Strong leadership, project management, and technical writing skills• Minimum of seven (7) years in QA/Regulatory Compliance in the pharmaceutical industry (desired)• Prior experience leading/managing regulatory inspections (desired)• Experience managing Quality Systems (desired)• ASQ certifications (e.g. CQA, CQE, CQM) (desired)• Active member of pharmaceutical trade associations such as ISPE, PDA, etc. (desired)
Benefits
• On-site fitness center access• Lunch & learns• Sustainable office working environment• Team, site, and family activities• Life-long learning• Diversity & inclusion• Tuition reimbursement• Dining center