Job Information
Cambrex High Point Stability Manager in Waterford, Ireland
Company Information
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
Supervision, coordination, and administration of stability operations, with a strong focus on team management and quality assurance.
Responsibilities
Responsibilities: Reporting to the Managing Director, specific responsibilities include but are not limited to:
Operational Activities:
Oversee the daily operations of stability storage, ensuring that all processes are carried out efficiently and in compliance with regulatory standards.
Manage the receipt, placement, and monitoring of customer product samples, ensuring accurate documentation and adherence to study protocols.
Ensure that all stability operations are conducted in accordance with the company's Quality Management System (QMS) and current Good Manufacturing Practices (cGMP).
Liaise with various departments, including Quality, to ensure seamless integration of stability operations with overall company objectives.
Facilitate communication between team members, external consultants, and contractors to ensure alignment and efficient workflow.
Maintain comprehensive records of all stability operations, including study paperwork, monitoring equipment logs, and QMS documentation.
Ensure that all administrative tasks, such as responding to emails, maintaining invoices, and managing contractor reports, are completed promptly and accurately.
Implement and oversee the use of new equipment and technologies to enhance stability operations.
Team Management:
Lead and manage a team of operational staff, providing guidance, support, and performance feedback to ensure high levels of productivity and morale.
Conduct regular team meetings to discuss progress, address challenges, and plan for future activities.
Develop and implement training programs to enhance team skills and ensure compliance with regulatory standards.
Foster a collaborative and positive work environment that encourages teamwork, innovation, and continuous improvement.
Manage schedules, workloads, and performance for team members.
Quality Assurance:
Oversee all QMS activities, ensuring that stability operations meet the highest quality and compliance standards.
Monitor operations, identifying areas for improvement and implementing corrective and preventive actions (CAPA) as needed.
Drive correct use of quality manuals and continuous improvement initiatives, working closely with management to drive quality improvements.
Ensure that all planned and unplanned changes (deviations) are thoroughly investigated, documented, and addressed.
Support the quality team with internal reviews and audits to ensure ongoing compliance with GMP certification and regulatory requirements.
Qualifications/Skills
Experience:
+ + Proven experience working in a regulated environment.
5+ years in team lead management or leadership roles.
Personal Attributes:
- Ability to lead and motivate a team, fostering a positive and productive work environment.
Excellent interpersonal and communication skills.
Strong problem-solving skills and a proactive approach to challenges.
Proficiency in IT tools (Word, Excel, Teams).
Commitment to continuous improvement and quality assurance.
Commercial awareness and business development skills.
Education, Experience & Licensing Requirements
Third Level Qualification in Science or a related field is desirable but not essential.
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.