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 2,000 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 Thank you for considering a future opportunity with Cambrex! If you are 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/Skills + Provide technical guidance for troubleshooting and investigating basic to complex issues. + Strong attention to detail, as well as time and resource management. + Strong personnel and professional integrity and trustworthiness with strong work ethics and the ability to independently with minimal direction. + Promote a safe environment for work. + Demonstrated knowledge of global GMP and regulatory requirements related to the pharmaceutical drug development / manufacturing process. + Advanced knowledge of FDA, EU, and ICH requirements and implementation for GLP and GMP in the pharmaceutical industry. + Communicate clearly and effectively both orally and in writing with internal and external clients. + Strong knowledge and understanding of LIMS and Empower, required . + Skilled in MasterControl , Trackwise and/or other QMS software applications. + Demonstrate the capability for continued upward growth and technical contributions. + Exceptional analytical and problem-solving skills with the proven ability to think strategically. + Demonstrated extensive knowledge and understanding in providing effective evaluation of laboratory practices such as raw material, drug substance, drug product and medical device testing, compendia methods ( e.g. USP/NF, EP, JP), and method validation/qualification/transfer. + Highly effective team and interpersonal skills with the ability to work across numerous scientific and management disciplines. + Excellent diplomatic, analytical, and communication skills – both verbal and written. + Ability to develop and manage a high-performance team focused on quality, accountability and meeting and exceeding expectations. + Strong Computer Skills + Microsoft Suite, proficiency Education, Experience & Licensing Requirements + Related BA/BS, r equired . + 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. 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.