Site Head, Quality

Company Information

You Matter to Cambrex.

Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With more than 40 years of experience and a growing team of over 2,400 professionals servicing global clients, Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing.

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

Reporting, in a matrix organizational structure, to the General Manager, the  Site Quality Head is in charge of Quality Assurance, Quality Control, Analytical Development and Quality Compliance, ensuring compliance with current Good Manufacturing Practices (cGMP) as they pertain to the local regulation and exporting countries regulation as applicable. (such as FDA, ANVISA, MHRA, EMA,  Health Canada). 

Responsibilities

• Responsible for the Site Strategy realization.

• Responsible for the site State of Control of Compliance by oversighting the System Based Owner programs by Quality System Elements.
• Overall responsibility for quality operations and initiatives, including:
• Quality Assurance management:
• In collaboration with the Quality Assurance team, responsible for:
• Documentation control (master batch record, specification & method)
• Batch record review and product disposition
• Investigations, complaints, deviations, CAPAs, APRs
• Production and Pharmaceutical Development support
• APRs, GMP training and SOP review
• Validation /qualification documentation review & approval
• QA Operations – inspection, sampling, and review of incoming materials, perform AQL inspections, support and drive compliance throughout the site
• Develop, maintain, and enhance training programs and systems at Cambrex
• Driving key compliance initiatives such as Data Integrity, Training Program Enhancements, Quality Documentation System Enhancements,other identified initiatives.
• Departmental budget development and compliance

 

• Quality Compliance management:
• In collaboration with the Quality Compliance team
• All audits, internal, external – regulatory, client and vendor
• Vendor management program
• Quality Agreements with clients & contractors
• License renewals

 

• Budget:
• Plan and monitor the Quality department’s annual budget on a monthly basis, according to Cambrex guidelines and develop any action plans necessary to ensure spending is within budget commitments. .
• Leadership:
• Manage, develop and motivate the Quality Team:
• Make decisions pertaining to the workforce according to the company’s current policies and guidelines.
• Implement an efficient organizational structure.
• Support continuous improvement and/or cost reduction project.

• Determine the professional development needs among its managers and the quality group and elaborate action plans in collaboration with the Human Resources Department.
• Develop and Maintain Key Performance Indicators for the Quality Operation and discuss performance/opportunities.
• Sponsor of the Tier boards performance management governance.
• Own the Behavioral Based Safety program including corrective actions required.

• Coach employee & share expertise in quality aspect, decision making and problem solving.
• Ensure a strong relationship with Cambrex’s customers.
• Supports the Customer Experience and PMO strategy realization.
• Other duties as assigned.

Qualifications/Skills

• Analytical and problem-solving skills required.
• Compliance expertise required.
• Financial skills required
• Strategic Planning
• Capacity Management
• Project Management
• Presentation Skills
• MS Applications proficiency

OTHERS

• May be required to wear personal protective equipment.
• Must be able to move about the facility.
• Must be able to remain sedentary for periods of time.

Education, Experience & Licensing Requirements

EDUCATION:  

Bachelor of Science (B. Sc.), Masters in science preferred, related to the OSD pharmaceutical industry.

 

 

EXPERIENCE:

• 15 years of experience in a pharmaceutical environment, in Quality Operations, with FDA Audit experience.
• Extensive knowledge of US, ICH and EU current Good Manufacturing Practices.
• Expertise in Analytical Development and Quality Control Laboratory Operations.
• Mastery of English- oral and written.
• Microbiological services experience either through direct or line management.
• Experience with a CDMO would be preferable.
• Excellent knowledge of validation requirements.

 

 

 

Cambrex is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

 

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