Quality Assurance Manager
PharmaRegulatory AffairsQuality Assurancegmpemacroraveinformsap
Job description
Job Description For over 130 years, we have pioneered groundbreaking science. Today, we are driven by continuous innovation to develop breakthrough medicines, vaccines and technology. Rooted in direct experience on the farm and in the clinic, we work hand in hand with our customers every step of the way. Our singular focus is to empower those who care for animals, helping them manage their vital responsibility with confidence. Because when it comes to animal health, no one sees it like we do. Job Description: The Quality Manager is a hands-on role that requires aptitude, energy to build a QMS from the ground up. We are in the midst of a significant culture change. The successful candidate needs to drive for results. This operation does not fall under regulatory guidelines, therefore, a regulatory understanding or background is not needed. However, the Quality Manager will be the champion for quality by design and continuous improvement that ensures every product is processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality. The Quality Manager partners across our internal manufacturing facilities, external contract manufacturers and suppliers to create an interdependent global manufacturing network committed to deliver a compliant, on time, and reliable supply to customers. This position receives direction from the Associate Director of Operations, interfaces directly across all functional areas and interacts daily with senior leadership. SPECIFIC RESPONSIBILITIES: Support implementation of all Quality processes Coordinate Quality activities for the assigned manufacturing unit. Analyze quality data to make recommendations for improvement focus areas. Develop and implement improvements via Kaizens. Work closely with Engineering to influence technical design decisions, meet custom product requirements, and reach business objectives. Implement containment, corrective actions and follow-up on quality issues – including facilitation of responses to findings and handling of Quality case documentation. Lead effective problem solving activities to investigate nonconformities. Serve as Quality liaison with support groups and cross functional teams. Coordination of Quality training Primary liaison for supplier quality activities Writes, reviews, and approves Standard Operating Procedures, Controlled Job Aides, Control Procedures, Quality Standards, etc. Promotes company strategic, departmental operational excellence and manufacturing regulatory initiatives. Accountable for acting as the quality representative on capital projects. Provides engineering and technical support for current products and new product launches. Interfaces with customer quality representatives concerning quality problems and assures that effective corrective action is implemented. Interprets customer specifications and requirements. Maintains good internal and external supplier quality levels. Designs and implements methods for process improvement, testing and inspection. Develops and analyses quality metrics and initiating change as needed. GENERAL REQUIREMENTS: Key Competencies: Ability to work with all levels of business customers in a highly dynamic environment. Comfortable with working closely across various teams including functional and procurement leadership teams. Willingness and ability to work flexible working hours. Qualifications: Education Minimum Requirements BS Degree in Mechanical or Industrial Engineering preferred, or equivalent work experience may be considered. Minimum of five years of quality engineering experience in a manufacturing environment preferred. Required Experience & Skills Effective written and verbal communication skills. Strong supervisory and leadership skills; experience leading a team. Experience with SAP ERP system. Time Management: Ability to manage changing workload, and complete tasks independently. Demonstrated analytical, Problem Solving/Decision Making: logical approach and acting despite obstacles or ambiguity. Ability to understand technical specifications and requirements. High Proficiency in Excel, Word, PowerPoint; familiarity with Power BI and Access a plus Solid understanding on quality tools such as statistical process control, such as Pareto charts/8D problem solving, FMEA, GR&R, FAI, CPK, PPAP etc. Ability to lead and facilitate training and continuous improvement initiatives. Required Skills: Analytical Problem Solving, Analytical Problem Solving, Analytical Thinking, Capital Projects, Case Documentation, cGMP Compliance, Decision Making, Detail-Oriented, Driving Continuous Improvement, Enterprise Resource Planning (ERP), Key Performance Indicators (KPI), Operational Excellence, Oral Communications, People Leadership, Process Improvements, Quality Auditing, Quality Control Systems, Quality Documentation, Quality Management Standards, Quality Management Systems (QMS), Root Cause Analysis (RCA), SAP Business Technology Platform (SAP BTP), SAP Enterprise Resource Planning (ERP), SAP Project System (PS), SAP Systems {+ 1 more} 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: <a href="https://www.eeoc.gov/sites/default/files/2022-10/22-088_EEOC_KnowYourRights_10_
Stand out for this role
NoxPharm tailors your CV to this job description by aligning your experience with the role requirements and terminology. Built for pharma & life sciences.
Tailor my CV now — free to trySimilar Pharma jobs
Mechanical Assembler
Thermo Fisher Scientific — Eindhoven, Netherlands
CRA (Level II)
Thermo Fisher Scientific — 2 Locations
Application Scientist
Thermo Fisher Scientific — Shanghai, China
Biostatistician II
Thermo Fisher Scientific — Beijing, China
Sr Project Mgr
Thermo Fisher Scientific — Beijing, China
Programmer Analyst
Thermo Fisher Scientific — Guangdong, China