Quality Lead at Cambrex – Waterford, New Jersey

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.

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.

• 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.

• This is a full time, permanent position
• Hours are 8.30am to 5pm, Monday – Friday

• 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.