Director, Process Support & Quality Control

Overview

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 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.

You Matter to 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 in a safe environment, and strengthen connections with coworkers and the community. We offer a competitive benefits package that includes healthcare, life insurance, retirement planning, and more.

Your Future Matters. Known for customer-focused scientific and manufacturing excellence, we offer a range of career and growth opportunities across our global network of locations. Start a career where You Matter by applying today!

The Director of Quality Control is accountable for the overall management of Process Support, Raw Materials, Quality Control, and Stability operations at the site. The Director will ensure that all operations are conducted in compliance with cGMP regulations, relevant compendial requirements, company policies, standards and procedures and safety standards. The Director will ensure that lab systems and resources are appropriately organized and managed to support accurate and timely completion and approval of results, validations or transfers to ensure client, customer and project needs are delivered in the most efficient and optimal manner.

• Manage and direct the overall site Quality Control laboratories (Raw Material, Process Support, and Quality Control) to deliver accurate and timely testing results
• Oversee the Stability and Reference Standard programs
• Direct the implementation and consistent execution of controls for data integrity, documentation, sample management, reagent and reference standard management, instrument and equipment management controls
• Develop and maintain a high skilled and agile team of analysts and personnel to support optimal service delivery and maintain high levels of compliance and inspection readiness
• Manage and direct site implementations of key laboratory management systems including LIMS, ELN, CDAS, and reference standard management tools
• Work closely with Quality Assurance to ensure implementation of the requisite controls to assure data integrity
• Review and approve instrument and method qualification/validation and transfer protocols and reports, ensuring that the appropriate quality standards have been incorporated and affirmed during the execution of these studies
• Manage, in collaboration with all stakeholders, the QC activities that affect production and validation activities. Anticipate and resolve issues to attain required deadlines and ensure continual communication of status
• Manage the Deviation program process within the laboratories that ensures thorough and timely investigations are completed to correctly identify root causes and develop and implement robust and comprehensive CAPAs
• Administer appropriate escalation of critical events to Senior Leadership and ensure close communication with clients on quality issues potentially impacting their product or process
• As needed, directly assist in site critical investigations
• Interface directly with client stakeholders for quality or compliance issues associated with lab operations and testing
• Oversee and manage lab change control program; review and provide input to change controls
• Oversee compendial review program to ensure site methods align with current compendia and ensure adequate assessment of potential impacts to qualified methods as part of this review
• Review and approve SOPs as required
• Oversee and manage departmental performance and quality metrics
• Develop and mentor staff
• Prepare and manage departmental budgets, monitor and control spending
• Oversee the purchase, use, and maintenance of various analytical instrumentation
• Assist Project Management in developing resource and cost structures for client project proposals and statements of work
• Performs all other related duties as assigned

• Demonstrated, well developed analytical and problem-solving skills
• In depth knowledge of GMP regulations and guidance of US FDA, EU in particular data integrity and various compendia (USP, EP, JP)
• Technical understanding of instrumentation, computerized systems and method validation
• Ability to serve as a subject matter expert with clients and regulatory bodies for quality issues/investigations
• Detail focused and strong attention to detail and accuracy
• Strong presentation skills
• Adaptable and flexible in response to a dynamic…