Description Company is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. One shared journey is moving us forward at Company. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. And driven to make a difference, from innovative research to hands-on community support. Company recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives. This position is accountable for the management and success of the headquarters functional team responsible for developing, implementing and improving the product quality complaint management program in support of products released for commercial distribution. Accountable for ensuring that these responsibilities are maintained in accordance with GMPs, global health authorities’ requirements and expectations. MAJOR DUTIES AND RESPONSIBILITIES   • Responsible for management and oversight of end to end product quality complaint programs from intake to complaint closure.   • Understand the regulatory environment and work proactively to establish systems and procedures to assure that product quality complaints are managed in accordance with corporate policies and government regulations.   • Translate company and department strategy into effective department objectives   • Implement effective Quality Product Complaints processes including investigation procedures, documentation systems, tools, metrics and measurable improvements.   • Ensure monitoring and appropriate escalation of product quality complaints, including expedited complaints.   • Ensures activities related to product complaint investigations are captured and available for regulatory inspections.   • Ensure the development, measurement and reporting of performance and improvement metrics for the headquarters Quality Product Complaints function.   • Manage employee related activities for the headquarters Quality Product Complaints department (i.e., hires, trains, appraises, rewards, motivates, disciplines).   • Provide ongoing development, feedback, coaching, and mentoring to the headquarters Quality Product Complaints staff. Qualifications Education:   • Bachelor’s degree in chemistry, biology, engineering or related health science.   • Advanced degree preferred. Experience / Knowledge:   • A minimum of 10 years of pharmaceutical industry experience and demonstrated leadership in Quality and/or Compliance discipline with in-depth knowledge of global health authorities regulations and requirements   • A minimum of 5 years experience and in-depth knowledge of GMP requirements of Product Quality Complaint programs with direct experience involving United States as well as Rest of World programs   • Experience in Pharmaceutical or Biotech Manufacturing Operations   • Cross-functional experience in three or more areas (i.e. Quality Assurance, Product Quality Complaints, Manufacturing, Regulatory, Medical Information, Pharmacovigilance etc.) is required   • Subject matter expertise in regulatory requirements and expectations in Product Quality Complaints and/or Quality Assurance is required   • Ability to effectively translate and communicate health authorities regulations   • Analytical skills to interpret, predict and improve process and performance   • Ability to establish effective relationships, cooperation and alignment of objectives within Quality and with internal partners including medical information, pharmacovigilance & epidemiology, commercial operations and manufacturing   • Demonstrated management capability with ability to make and act on decisions while balancing speed, quality and risk   • Ability to provide innovative ideas to improve quality and compliance that create value including seeking new information and external insights   • Demonstrated experience with Risk Management Decision Making   • Lean Six Sigma/Black belt certified desired   • Active in external forums and societies relevant to Quality and product complaints   • Strong verbal and written communication skills   • Excellent influencing, facilitation, negotiation and project management skills Travel required:   • Up to 20% travel nationally and internationally.   • Overnight absences required for travel. Extended overnight stays of a week or more are infrequent for routine travel.   • Manager of People