Company Information
You Matter to Cambrex.
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 comprehensive 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.
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 of Quality Assurance is responsible for the daily operations of the Quality Assurance team in a CDMO environment. This role will work with manufacturing and analytical operations to ensure that all activities are in compliance with company SOPs, cGMP/cGLP standards and FDA/EU regulations.
The Manager of Quality Assurance leads and mentors the quality team and is expected to be an integral part of the QA management team. This role will interact with clients and is responsible for successfully meeting client and departmental objectives and metrics.
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.
Responsibilities
• Lead and facilitate a positive quality culture with all Cambrex employees and external partners. • Represents the department in external client and internal meetings, collaborates and cooperates to achieve cross-functional improvements and business goals. • Manage quality events (deviations, OOS records, change controls, and CAPA) in the QMS. • Creates departmental systems that foster a culture of quality and continuous improvement focused on value to the customer. • Ability to manage a high-performance team focused on quality, accountability and meeting and exceeding expectations. • Ability to host and/or participate in internal, client and/or regulatory audits. Works with the site management in all areas to maintain a cGMP compliant facility in a constant state of inspection readiness. • Exercises judgment within defined procedures and practices to determine appropriate action for quality events. • Facilitates the development, implementation, and maintenance of procedures and policies to comply with FDA, EU, and ICH requirements applicable to site’s needs. • Recruits, trains, develops, and retains staff for the effective process of departmental operations. • Effectively resolves quality issues and concerns in a timely manner. • Drive customer deliverables in a timely manner by managing batch record review and execution, batch release, and reporting of analytical data. • Effectively manage and organize tasks to help drive the activities of others; while performing a variety of duties on schedule, with accuracy. • Creates strong and effective working relationships with Quality team, colleagues, and clients.
Qualifications/Skills
Required Knowledge/ Skills/Abilities
Knowledge: • Experienced with review and approval of raw material, starting material, and finished product specifications. • Experienced with review and approval of batch records supporting small molecule API and/or finished solid oral dose drug product. • Experienced with review and approval of equipment and instrument validation as well as associated computer software validation. • Provide technical guidance for troubleshooting and investigating basic to complex issues with minimal direction. • Strong attention to detail, as well as time and resource management. • Strong personal and professional integrity and trustworthiness with strong work ethic. • Promote a safe environment for work. • Knowledge of global GMP and regulatory requirements related to the pharmaceutical drug development / manufacturing process. • Communicate clearly and effectively both verbally and in writing with internal and external clients. • Skilled in LIMS, MasterControl, Asset Management System, and Trackwise and/or other QMS software applications.
Skills / Abilities: • Strong analytical and problem-solving skills with proven ability to think strategically. • Demonstrated understanding of current FDA, EU and ICH requirements and implementation for GLP and GMP in the pharmaceutical industry. • Effective team and interpersonal skills with the ability to work across numerous scientific and management disciplines. • Strong Computer Skills • Microsoft Suite proficiency
Education, Experience & Licensing Requirements
• Related BA/BS, required. • 8+ years of relevant experience in a CDMO and/or pharmaceutical environment, preferably in Quality Assurance. Experience in clinical phase manufacturing is desired. • At least 2-3 years of experience in a leadership role directly supervising staff, preferably in pharma or biotech.
Travel: None
Physical Demands:The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee may be required to use hands to finger, handle, or feel and to reach with hands and arms. The employee is required to talk and hear. The employee is frequently required to stand, walk and sit. The employee may be occasionally required to climb or balance. The employee may be required to regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, and peripheral vision.
Environment and Protective Equipment:The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee may be occasionally exposed to moving mechanical parts, high precarious places and vibration. The noise level in the work environment is usually quiet. The employee may be required to gain access to lab, manufacturing or clinical areas for inspections or work discussions. The employee is required to wear the appropriate personal protective equipment to perform the job duties. Such personal protective equipment may include but is not limited to: safety eyewear, various types of respirators/breathing apparatus, lab coats, gloves, etc.
The hiring range in Colorado for this position is $110,000/year - $145,000/year; however, base pay offered may vary depending on job-related knowledge, education, skills and experience of the applicant, internal equity and alignment with market data. This information is provided per the Colorado Equal Pay Act. This position includes a competitive benefits package.
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.
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