Company Information

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You Matter to Cambrex.

Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance development and manufacturing across the entire drug lifecycle, as well as comprehensive analytical and IND enabling services.

With over 40 years of experience and a team of 2,000 experts servicing global clients from North America and Europe, Cambrex offers a range of specialized drug substance technologies and capabilities, including continuous flow, controlled substances, liquid-phase peptide synthesis, solid-state science, material characterization, and highly potent APIs.

Your Work Matters.

At Cambrex, we strive to build a culture where all colleagues have the opportunity to:

engage in work that matters to our customers and the patients they serve
learn new skills and enjoy new experiences in an engaging and safe environment
strengthen connections with coworkers and the community

We’re committed to attracting and nurturing a passionate team of valued professionals in our fast-paced and growing company. We offer a competitive benefits package that includes healthcare, life insurance, planning for retirement, and more!

Your Future Matters.

Known for our customer-focused scientific and manufacturing excellence, as well as our strong commitment to quality and safety, we offer a range of career and growth opportunities across our global network of locations. Together with our customers, we aim to improve the quality of life for patients around the world. Start a career where You Matter by applying today!

Job 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

Education, Experience & Licensing Requirements

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.

Cambrex is committed to providing a safe and productive work environment. All offers of employment are contingent on the successful completion of a comprehensive pre-employment screen. The pre-employment screen may consist of several components including but not limited to a drug test, criminal record check, identity verification, reference checks, education and employment verification, and may vary based on federal, state, and local laws. Refusal to submit to testing will result in disqualification of further employment consideration.

All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities. Cambrex Corporation is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), ancestry, national origin, place of birth, age, marital status, disability/handicap, genetic information, veteran status, or other characteristics protected by federal, state, and/or local law.

Quality Lead

Benefits

Job Description