<p>Manager, Quality Systems and Compliance - Burlington, MA</p> <p>Build your future at Curia, where our work has the power to save lives.</p> <p>The Manager, Global Quality Systems and Compliance is an integral part of the Curia team, contributing to our success by being responsible for the oversight and progression of strategic projects to support implementation and maintenance of the Global Quality system at the site. The role includes design and development, and/ or refinement of a Global Quality system that aligns ICH Q10 and all applicable regulatory guidance.</p> <p>Curia is a global contract development and manufacturing organization (CDMO) with over 30 years of experience partnering with pharmaceutical and biotech companies to provide life-saving treatments to patients. At Curia, we are on a mission to advance our customers' therapies from curiosity to cure and ultimately to improve patients' lives.</p> <p>Responsibilities</p> <ul> <li>Lead continuous improvement of Quality Systems, such as CAPA, Deviation, Investigation, and Change Management, and direct the efforts to develop, implement and maintain compliant and effective Quality Systems </li><li>Identify and lead quality systems improvement initiatives by working closely with Global/ BU Quality departments and other key stakeholders </li><li>Support Quality Systems by driving regulatory compliance and continuous improvement activities in accordance with applicable regulations and business goals and objectives </li><li>Ensure compliance with global regulatory requirements (e.g. FAD, EMA, ICH) and industry standards </li><li>Lead Inspection readiness meetings </li><li>Lead product complaint investigation for commercial clients </li><li>Oversee the Document Control </li><li>Provide oversight for the supplier qualification program. This includes performing vendor audits, drafting risk assessments etc. </li><li>Provide leadership and management within the department through a structural process of objective setting, performance appraisal, and individual development as appropriate </li><li>Participate and present at the Quality Management review meetings </li><li>Participate in FMEA's, gap assessments and drive regulatory compliance </li><li>Provide audit support (Regulatory, Client and Internal). This includes leading the backroom, providing front room support, performing internal audits) </li><li>Recommend, implement, and administer OTJ and classroom training to enhance employee work performance </li><li>Work with cross functional teams to develop knowledge/skill assessment testing using provided tools, for employees in line with department/job requirements </li><li>Publish weekly, monthly and quarterly leading indicator metrics to the Site Leadership and above site leadership </li><li>Monitor Quality Systems for trends and notify management of events requiring and immediate action </li><li>Lead department projects of varying complexity </li><li>Up to 20% travel </li></ul> <p>Requirements</p> <ul> <li>Bachelor's degree in Chemistry or a related field </li><li>Minimum 7 years of quality experience in the pharmaceutical and/or medical device industry, including 2 years in a management role in team leadership of professional level individual contributors </li><li>Experience with Quality Systems and in IT solutions for document management, training, deviations, CAPA, change control, LIMS, etc. </li></ul> <p>Preferred</p> <ul> <li>Advanced degree in Science or Engineering </li><li>Lean Six Sigma certification (green or black belt) </li></ul> <p>Education, experience, location and tenure may be considered along with internal equity when job offers are extended.</p> <p>We do not accept unsolicited assistance from any headhunters or recruitment firms for any of our job openings. All resumes or profiles submitted by search firms to any employee at Curia, in any form without a valid, signed search agreement by an authorized signatory in place for the specific position, approved by Talent Acquisition, will be deemed the sole property of Curia. No fee will be paid in the event the candidate is hired by Curia because of the unsolicited referral.</p> <p>All interested applicants must apply online. Please be aware of scammers. Curia will only send offer letters and requests for sensitive personal information from a curiaglobal.com email address. Curia is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Curia is an E-Verify employer.</p>