Manager, Quality

Job Requisition ID:

32744

Department:

QUALITY Category:

Quality Location:

Hattiesburg Mississippi Come and Save Lives with Us! SERB is a fast-growing specialty pharmaceutical company that equips healthcare providers worldwide with life-saving medicines for patients facing rare conditions and emergencies. For over 30 years we have consistently provided emergency medicines, medical countermeasures, and the world's leading portfolio of antidotes. Today SERB has over 500 employees in 18 countries and group revenue in excess of €400m. With a strong presence in the US, Europe, and the Middle East, along with a global network of trusted distribution partners, we make a broad range of essential medicines available in over 100 countries. Having the right culture is as important to us as having the right portfolio. We are guided by our four values: We make patients our priority We act with accountability and integrity We work together as one team We look for better ways forward By expanding our reach through selective acquisitions and entering new markets, we're not just supplying medicine; we're improving the standard of care for more patients around the world. Broad Overview The Manager, Quality will provide leadership and oversight for all quality activities at the site, ensuring compliance with regulatory standards and internal procedures. This role is responsible for managing Quality Assurance and Quality Control operations, including product release, documentation, compliance, and continuous improvement initiatives. The Manager, Quality will lead the site quality team (consisting of 1 Quality Analyst), align local processes with global standards, and serve as the primary point of contact for regulatory inspections and customer quality issues. The ideal candidate will have a strong background in medical device or pharmaceutical quality systems, proven leadership experience, and a commitment to maintaining high standards of product quality and regulatory compliance. This individual is expected to work on site at our Hattiesburg, MS facility and report into the Sr. Manager of Quality. As Manager, Quality, your responsibilities will include: On site Quality Leadership for medical device production representing all quality oversight Quality release of incoming goods and finished medical device products in compliance with

ISO 13485, MDSAP, EU MDR, UK

MDR, and internal procedures Local ownership of the eQMS and DMS systems ensuring compliance with internal procedures and regulatory requirements and standards. Quality Assurance approval of GxP documentation such as SOPs and forms and updating training system to ensure compliance Direct quality oversight for site Quality Assurance and Quality Control operations including deviation, CAPA, Document Control, Change Control, and Product Testing Coordinate Quality Control testing of in-coming goods with supply chain and production to ensure on-time delivery of products Review and Quality Assurance approval of compliance documentation such as change controls, CAPA, quality events, change controls, validation protocols and reports. Receipt and quality investigation of customer complaints with interface as company representative to customers as required Prepare trend reports for quality metrics and report to upper management and identify and escalate quality trends as appropriate Identify areas for improvement in compliance and support improvement projects within the business Hiring of quality personnel and approval of timecards and PTO Management of employee(s) with various levels of experience and ensure employee development Alignment of the local quality system with global policies and processes Represent Quality Assurance and Quality Control during notified body and government agency inspections and support of activities to correct identified nonconformities The above duties and responsibilities are not an exhaustive list, and you may be required to undertake any other reasonable duties compatible with your experience and competencies. This description may be varied from time to time to reflect changing business requirements. To be successful in this role, you should demonstrate: Bachelor's degree in life science, pharmacy, chemistry, engineering or related discipline Relevant experience of minimum 5 years in Quality for pharmaceutical or medical device manufacturing Experience as a supervisor or manager Experience in eQMS systems preferred Experience participating in GMP audits Leadership and motivational skills Root cause analysis and risk assessment Self-motivated and results oriented driven Company Benefits Vacation, Personal and Sick time 15 Paid Company Holidays Medical, Dental, Vision and other Voluntary benefits Paid Parental Leave Tuition Assistance Discretionary Bonus Plan Competitive 401(k), $1 for $1 up to 6% of pay. The safe harbour match is vested immediately. In addition, SERB also offers a discretionary match of up to 4% of pay which vests 20% a year for 5 years. S erb Pharmaceuticals is an equal opportunity employer. We offer competitive compensation & benefit packages, challenging opportunities and a culture of working together in a supportive way built on our strong foundation of values.