Cambrex Hiring for Manager, CSV at Durham, North Carolina, United States Full Time

Job Details

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 years of experience and a growing team of over 2, 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

The Manager for Computer Systems Validation will lead the Cambrex Global organization validation department through the support of the Quality value stream.

This role will manage a group of internal CSV personnel and external consultants to implement the required compliance to us information systems under GMP.

This role will work with highly complex lab / manufacturing systems and software applications and ensure they are implemented according to regulatory requirements and maintain compliance throughout the system lifecycle.

You will work in a global organization and interact with personnel from several locations and departments.

Responsibilities

• Lead CSV activities in a multi-location organization with geographically dispersed CSV group.
• Support and become a champion of the SAFe framework.
• Collaborate with the Agile Team to clarify requirements and develop global policies that can support a single QMS system across Cambrex.
• Build and maintain a CSV program that involves management of personnel, resources, and multiple concurrent projects.
• Build business cases for new features and conduct impact analysis as requirements emerge.
• Manage internal / external CSV personnel to facilitate completion of systems validation activities.
• Work with other Product Owners to ensure dependencies are prioritized appropriately across teams.
• Mentor junior Product Owners to improve agile approaches and develop a stronger teams.
• Inspect completed work against requirements, customer needs, and business needs
• Challenge assumptions and direction from business stakeholders when their needs are not technically achievable.
• Research and understand market requirements and trends.
• Lead and champion digital product strategy and roadmap in collaboration with key internal external partners
• Identify and qualify all computer systems which impact cGMP operations using a risk-based methodology and best practices based on GAMP.
• Represent CSV during audits of internal computer systems validation activities, protocol / procedures, and prepare responses for the QA team.
• Ensure initiation / preparation and closeout of all CSV related deviations and change control documents.
• Work closely with The Quality Value Stream Leader, Business Technology Leaders, and the QA team Compliance to ensure appropriate validation of cGMP computer systems.

Qualifications / Skills

4-year degree in an accredited university and Master’s degree; BS degree in Computer Science, Life Science, or Engineering;

Master’s degree preferred

• At least 5 years of CSV experience in an FDA regulated company.
• Proven interpersonal and communication skills
• Undergraduate degree and / or equivalent work experience.
• Experience with CFR Part compliance strongly preferred
• Good verbal and written communication skills.
• Experience in the review, evaluation, and testing of systems to ensure compliance with the FDA Electronic Records / Electronic Signatures regulation and CFR Part .
• In-depth understanding of CFR Part and CSV processes
• Strong people management skills
• Excellent project management skills
• Strong overall knowledge with IT infrastructure and applications
• Able to work in a global and matrix environment.
• Should demonstrate ability to manage multiple tasks and competing priorities, driving towards completion.
• Demonstrated project management skills and project management software skills, including planning, organizing, and managing resources
• Experience in SDLC and methodologies associated with it (Scrum, Agile, SAFe)
• Self-starter who can work well independently or in groups.

Education, Experience & Licensing 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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