Quality Lead

Quality Lead at Cambrex Quality Lead at Cambrex in Waterford, New Jersey Posted in 4 days ago.

Job Description:

Cambrex Quality Lead IE--Waterford Job ID:

2026-4791

Type:

Regular Full-Time # of

Openings:

1

Category:

Quality Cambrex - Waterford Overview We are seeking applicants for the position of Quality Lead to join our team. This role will report directly to the Quality Manager for Waterford and will be a pivotal role in our growing Quality department.

Responsibilities Key Responsibilities:

Provide expert guidance and support to the Company on all Quality Management System (QMS) activities. Ensure all company operations comply with internal QMS requirements and applicable cGMP, GxP, and ISO standards. Maintain, monitor, and continuously improve the QMS by identifying risks, proposing enhancements, and driving corrective and preventive actions (CAPAs). Oversee the administration and maintenance of quality manuals, procedures, and records, and lead continuous improvement initiatives in collaboration with management. Ensure all planned and unplanned changes, deviations, and non-conformances are appropriately investigated, documented, and closed in line with regulatory expectations. Plan, conduct, and report internal audits to ensure ongoing compliance with GxP and ISO certification requirements. Serve as the Quality Lead for all internal, regulatory, supplier, and customer audits, including audit preparation, hosting, follow-up, and closure of audit findings. Quality Documentation & Administration Responsibilities Manage controlled documentation within the QMS, including the issuance, revision, and archiving of quality documents such as logbooks, protocols, and forms. Maintain document control systems and indexes (electronic and hard copy), including document numbering and version control. Review completed quality documents to ensure accuracy, completeness, and compliance with approved specifications and procedures. Propose, review, and implement document changes as required to support operational and regulatory needs. Verify second-person reviews and signoffs for operational documentation where required. Provide Quality oversight support for operational activities. Performing daily checks of stability cabinets and controlled room conditions when required. Supporting sample receipt, inspection, and dispatch activities as appropriate. Deliver general quality and administrative support as needed.

Qualifications / Skills

Hands on experience with core Quality system activities such as Deviations, Investigations, Document Management and Audits. Understanding of regulatory inspection readiness and data integrity principles (ALCOA+) A proactive self‑starter with strong organisational skills, capable of independently managing priorities and delivering high‑quality work to deadlines. Excellent communication skills, with the ability to present complex information clearly and confidently to both team members and management. A collaborative, team‑focused mindset, committed to building strong working relationships and performing effectively in a fast‑paced environment. Hours of Work This is a full time, permanent position Hours are 8.30am to 5pm, Monday - Friday Qualifications Level 7 or 8 qualification in a relevant discipline such as Quality, Science, Chemistry, Biotechnology or related field. Equivalent combination of education and experience may be considered. Minimum of 5+ years' experience working in a GxP regulated environment, including experience leading Quality activities, projects or junior team members. Equal employment opportunity, including veterans and individuals with disabilities. PI284035445