Change Control & Deviation Management Lead

Job description

Job Description JOB DESCRIPTION & SPECIFIC OBJECTIVES The Senior (Sr) Specialist, Change Control and Deviation Management role will be involved in implementation and maintenance of Change Control and Deviation Management procedures at our Company's Wilmington Biotech. The Sr Specialist will ensure the processes conform to our Company’s policies and comply with Current Good Manufacturing Practices (CGMPs), Health Agency regulations, and all other applicable governing regulations, with the mission and ambition to manufacture breakthrough medicines for patients around the world. mer Close collaboration with high-performance talent from our Company’s global team, the site team, and the biotechnology industry to develop and execute these Quality Management Systems and processes will be key. The successful candidate will be an individual and team member who supports building the future of our Company’s antibody drug conjugates and high potent compounds through a Quality culture that delivers unconstrained supply, that is ‘Right First Time’, to patients worldwide. As necessary and when applicable, providing training and guidance on the interpretation and implementation of our Company's policies and regulatory requirements will also be key priorities for the Sr Specialist. Throughout development of the new Wilmington Biotech facility, the successful candidate will focus on the deployment and maintenance of Change Control and Deviation Management processes. POSITION RESPONSIBILITIES With energy and enthusiasm, the Change Control and Deviation Management Sr Specialist will: Establish and maintain robust systems for Change Control and Deviation Management, in alignment with the our Manufacturing Division Quality Management System (QMS), for the Wilmington Biotech site Manage and monitor the processes for the site, including but not limited to, providing guidance and support to Change/Deviation Owners, review the Change Management System dashboard, escalate Changes/Deviations with potential risk(s) accordingly, track and trend Deviations Serve as site Subject Matter Expert (SME) for the deviation management and change control system. Will monitor performance of the site change control and deviation management system, providing structure for performance monitoring across the site teams. Support compliance direction for the site by ensuring adherence to divisional policies and guidelines as well as regulatory requirements for Change Control and Deviation Management Provide Change Control and Deviation Management information necessary for the Annual Product Quality Review (APQR), as applicable and appropriate Responsible for provision of Change Control and Deviation Management metrics in relation to the Quality Council process Advocate continuous improvement in the Change Control and Deviation Management systems Serve as site topic lead for deviation management and change control and provide training to end users Take part in the Change Control and Deviation Management communities of practice/knowledge networks Support external CGMP audits (e.g., Regulatory Authorities, Global Quality) as SME in Change Control and Deviation Management Knowledge of US and European GMP guidelines, ICH, and other international regulatory requirements, as applicable to the site REPORTING STRUCTURE This position will report into the Site Quality Management Systems (QMS) Lead. QUALIFICATIONS & EXPERIENCE - KNOWLEDGE AND SKILLS REQUIREMENTS General This role requires a seasoned individual with a minimum of 5 years’ experience in Quality Control, Quality Assurance or Pharmaceutical, Vaccine or Biological Operations, or Technical Operations. A self-starter and results-focused, the successful candidate will have contemporary knowledge of relevant CGMPs, regulations, and current industry trends. Technical Must have at least 1 year of operational experience Must have experience in Change Control and Deviation Management People Demonstrated knowledge of global health authority regulations and quality and compliance requirements with the ability to effectively communicate these requirements Knowledgeable in Industry Best Practices for quality and compliance related topics Strong collaboration and cross-functional skills to support continuous improvement, promote knowledge sharing, and implement best practices across the site and Compliance functions on global and local levels Strong verbal and written communication skills, as well as project management skills Demonstrated ability to influence areas not under direct control to maintain compliance with the requirements of the Change Control and Deviation Management systems Demonstrated ability to make and act on decisions while balancing speed, quality, and risk Education Bachelor's degree (or higher) in Chemistry, Biology, Microbiology, Automation, Engineering, or equivalent. Direct experience in manufacture of antibody drug conjugates and/or sterile manufacturing preferred. Required Skills: Adaptability, Antibody Drug Conjugates (ADC), cGMP Regulations, Change Management, Decision Making, Deviation Management, GMP Compliance, Good Manufacturing Practices (GMP), Performance Monitoring, Pharmaceutical Quality Assurance, Product Disposition, Project Management, Quality Assurance Processes, Quality Management, Quality Management System Improvement, Quality Standards, Regulatory Compliance, Self Motivation Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement​ We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts The salary range for this role is $106,200.00 - $167,200.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits. You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee