TALENT PIPELINE - Quality Assurance - Future Opportunities at Cambrex in East Rutherford, New Jersey

Job Description:

Cambrex


TALENT PIPELINE - Quality Assurance - Future Opportunities

US--

Job ID: 2025-4057
Type: Regular Full-Time
Category: Quality Assurance
Cambrex - Remote

Overview

Thank you for considering a future opportunity with Cambrex! If you interested in joining our team but don't see a current role that fits your background, please submit your resume here, If we have future opportunities that match your skillset, we will contact you.

While we are not currently hiring for a role linked to this specific posting, we would love to connect with talented individuals who are interested in potential future positions. By joining this talent pipeline, you will be the first to be notified when suitable opportunities arise within our Quality Assurance function.

Cambrex's Quality Assurance positions will be on-site at one of our 14 locations. Locations include: Agawam, Massachusetts, Charles City, Iowa, Durham, North Carolina, East Rutherford, New Jersey (HQ), Edinburgh, UK, High Point, North Carolina, Karlskoga, Sweden, Liege, Belgium, Longmont, Colorado, Paullo, Milan, Italy, Tallinn, Estonia, Waltham, Massachusetts, Waterford, Ireland, and Wiesbaden, Germany.

Responsibilities

Sample Job Description:

The Director of Quality Assurance is responsible for the daily operations of the Quality team and provides technical leadership in a CDMO environment. This position will drive the development and implementation of robust and lean quality systems and compliance frameworks for an analytically centered development and testing facility that supports both clinical and commercial clients. This role ensures that all quality activities are in compliance with company SOPs, cGMP/cGLP standards and FDA/EU and ISO 17025 regulations. Analyzes information for accuracy and compliance with internal procedure, CGMP and other regulatory guidelines.

The Director of Quality Assurance leads and mentors the quality team and is expected to be an integral part of the site leadership team. This role will interact across department functions and is responsible for successfully meeting client and departmental objectives and metrics and inspection readiness in a timely manner.

This role is responsible for managing and coordinating the activities of the assigned team. Staff may include salaried and/or hourly non-exempt employees. Ability to work within a dynamic and fast paced environment.

Key Job Responsibilities:

• Lead and facilitate a positive quality culture with all Cambrex employees and external partners.
• Represents the department in meetings, collaborates and cooperates to achieve cross-functional improvements and business goals.
• Creates departmental systems that foster a culture of quality and continuous improvement focused on value to the customer.
• Ability to develop and manage a high-performance team focused on quality, accountability and meeting and exceeding expectations.
• Directs, participates and/or supports client visits, client audits, regulatory audits and inquiries to ensure complete fulfillment of requests and interests.
• Generate/Evaluate audit responses to audit observations and ensure that proposed CAPA plans are suitable to address the observed deficiency and reduce risk to the business.
• Review evidence of CAPA completion and evaluate CAPA effectiveness during subsequent audits.
• Lead and drive continuous improvement of the audit program, and development of tools and processes utilized to facilitate the audit process.
• Authors and negotiates terms of Quality Agreements with clients as needed.
• Oversees vendor management program, supplier certification and qualify GxP vendors, as needed.
• Investigates deviations/events, issues and manages Corrective/Preventative Actions. Participates in creation and management of changes.
• Escalate issues to management in a timely manner implementing appropriate solutions, including Corrective and Preventative actions.
• Interpret applicable quality regulations/standards and create appropriate policies and procedures.
• Maintain current knowledge of updated regulations; industry guidance; and best practices to ensure optimal execution of the audit program.
• Works with the site management in all areas to maintain a cGMP compliant facility in a constant state of inspection readiness.
• Facilitates the development, implementation, and maintenance of procedures and policies to comply with FDA, EU, and ICH requirements applicable to site’s needs.
• Creates strong and effective working relationships with Quality team, colleagues and clients.
• Oversee GDP and date integrity to ensure that review and approval of all GxP data generated for projects are managed and evaluated as described in relevant protocol, SOP and regulatory requirements.
• Exercises judgment within defined procedures and practices to determine appropriate action for quality events.
• Recruits, trains, develops, and retains staff for the effective process of departmental operations.

Qualifications

• Related BA/BS, required.

• 12+ years of relevant experience in a CDMO and/or pharmaceutical environment, preferably in Quality Assurance.

• At least 5 years of experience in a leadership role directly supervising staff, preferably in pharma or biotech.

PI259432597

Salary:

$50,000.00

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