Supervisor, Quality Control Analytical

Build your future at Curia, where our work has the power to save lives.

Curia is a global contract development and manufacturing organization (CDMO) with over 30 years of experience partnering with pharmaceutical and biotech companies to provide life-saving treatments to patients. At Curia, we are on a mission to advance our customers’ therapies from curiosity to cure and ultimately to improve patients’ lives.

The Supervisor of Quality Control (QC) is responsible for oversight of the QC Analytical unit, at the direction of the Manager of QC, and for providing analytical technical guidance to the various site functions. This position's responsibilities include but are not limited to overseeing total quality control activities, such as testing and releases of raw materials, intermediates Drug Substance manufacturing, support to production, proper life-cycle of analytical methods (i.e. validation/qualification, transfer, review, approval, changes), OOS/OOT investigations, stability programs and compliance to the applicable compendial, regulatory and customer requirements. The Supervisor also ensures compliance of the analytical laboratories and operations to the most current data integrity requirements, drives continuous improvement activities and implementation of industry best practices in the QC laboratories to maximize efficiency while maintaining a high compliance level. The Supervisor will interact with Curia internal and external customers.

We proudly offer

• Generous benefit options (eligible first day of employment)
• Paid training, vacation and holidays (vacation accrual begins on first day of employment)
• Career advancement opportunities
• Education reimbursement
• 401K program with matching contributions
• Learning platform
• And more!

Responsibilities

• Supervise the QC Analytical unit. This includes, but is not limited to, scheduling and overseeing testing and operations of quality control team(s) responsible for samples and incoming, in-process and final products testing, coaching and mentoring QC Analytical analysts, supporting troubleshooting activities and investigations
• Ensure QC laboratories, and operations are cGMP compliant. This includes but is not limited to overseeing of analytical equipment qualification, maintenance and calibration programs, ensuring that QC procedures, practices and analytical methods are in compliance with the applicable compendial, regulatory and customer requirements and that QC investigations and thoroughly conducted
• Ensure that the QC functions are completed in accordance with the Company and governmental standards of safety and quality, and that all experimental documentation is complete and timely
• Partner with site stakeholders to achieve and maintain operational excellence, site quality compliance and a strong quality culture site-wide while maximizing efficiency of the QC laboratory to achieve the site business goals
• Collect, monitor and report quality control key performance indicators identifying and leading opportunity for improvements to achieve and maintain high quality, productivity and efficiency of the QC department
• Support Curia global quality and continuous improvements initiatives. Recommend and implement methods and techniques to increase the quality of products and/or service
• Oversee biologics analysis to support drug product manufacturing
• Mentor, coaches and provide in continuing training to QC personnel to increase the level of technical skills and compliance in the department

Education, experience, certification and licensures Required

• Bachelor’s degree in Chemistry, Analytical Chemistry or related field
• Minimum 8-12 years’ experience in the pharmaceutical industry in Biologics drug substance or drug product manufacturing, including 5 years’ experience in QC Analytical.
• Minimum 3-5 years’ experience in a professional management role

Preferred

• Advanced degree in Biology, Biochemistry, Analytical Chemistry or related field

Knowledge, skills and abilities

• Demonstrated experience with USP, EP, and other compendial methods
• Thorough knowledge of cGMP requirements with an understanding of phase-appropriate clinical and commercial expectations
• Demonstrated knowledge of FDA and EMA regulations, ICH analytical guidelines, method transfers, qualifications and validations
• SME-level understanding of core QC Analytical methods for release of GMP Drug Substance.
• Experience writing and reviewing technical protocols, data, and final reports
• Experience in conducting or supporting risk assessment, root cause analyses, and impact analyses
• Combined ability to mentor and coach individuals and ability to motivate teams to reach a common goal
• Experience in people management, resource allocation, and staffing strategies
• Task and team-oriented, analytical, organized, detail-oriented, self-motivated and ability to multitask
• Proficient with MS Outlook, Word, Excel and PowerPoint, and other electronic systems (Trackwise Digital, Dotmatics, LabVantage LIMS, Statistical Analysis software)
• Exceptional communication and interpersonal skills

Education, experience, location and tenure may be considered along with internal equity when job offers are extended.

We do not accept unsolicited assistance from any headhunters or recruitment firms for any of our job openings. All resumes or profiles submitted by search firms to any employee at Curia, in any form without a valid, signed search agreement by an authorized signatory in place for the specific position, approved by Talent Acquisition, will be deemed the sole property of Curia. No fee will be paid in the event the candidate is hired by Curia because of the unsolicited referral.

All interested applicants must apply online. Please be aware of scammers. Curia will only send offer letters and requests for sensitive personal information from a curiaglobal.com email address. Curia is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Curia is an E-Verify employer.

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