Director, Quality Remediation

Director, Quality Remediation 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. 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 The Director, Quality remediation, is responsible to provide support to global Curia sites in Quality and Compliance remediation . This role requires leading compliance remediation initiatives at sites undergoing remediation . Responsible to drive regulatory commitments by collaborating with site leadership. Play a key role to implement Curia global quality standards and industry best practices to Curia site quality assurance program. Work with site quality heads to establish and maintain a risk-based and science-based quality system to protect the public health and to meet customer and Curia's business needs and drive robust inspection readiness program. This role also requires to be on site for occasional interim site Quality roles. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Essential job duties + Lead Remediation Strategy and Execution + Own the end‑to‑end remediation program for quality issues, from root cause analysis to sustainable corrective actions. + Develop remediation roadmaps with timelines, milestones, and measurable outcomes. + Prioritize issues based on risk, regulatory exposure, and business impact. + Support GMP sites globally for remediation, for inspections & significant investigations Corporate Quality remediation lead and plays a key role in regulatory response development at the sites for major regulatory inspections + Ensure the sites have a robust inspection readiness program + Play a key role in the development of responses for inspectional observations, establish above site governance program to track CAPA commitments + Provide support and management through a structured program to improve the efficiency in quality processes while maintaining the cGMP compliance + Responsible for developing and leading Executive Quality Management Review as a delegate for the Head of Quality + Support the sites to implement global training programs at the sites and ensure the sites have a process to execute them on a routine basis + Support during regulatory agencies inspections and customer audits as applicable + Ensure sites develop and execute quality improvement projects to drive the continuous improvement initiatives at the sites + Embed Lean, Six Sigma, or similar methods into remediation work + Promote understanding of and compliance to Sterility Assurance related regulations such as the FDA's aseptic processing guide, EU Annex 1and other global regulatory agencies + Lead and/or support major investigations related to sterility assurance events (i.e, Adverse EM trends, media fill failures, etc.) + Identify opportunities to streamline processes and reduce defects + Help build a culture of proactive Quality rather than reactive fixes + Be available to take interim Quality leadership roles as necessary Education, experience, certification and licensures Required Bachelor's degree in Chemistry, Biology, Engineering or related field + Minimum 12-15 years' QA/RA experience at

USFDA, EMA

regulated facilities, including 8 years' experience in QA leadership or supervisory role + Direct experience leading USFDA inspections + Experience in Sterile, API and Biologics Products Quality Operations is preferred Knowledge, skills and abilities + Solid knowledge in FDA and other global regulations, especially the cGMP for the 21st century initiatives + Strong strategic thinking skills and tactical skills to apply as needed + Superior influential and negotiation skills + Good people leadership capabilities and conflict management + Strong understanding of organizational development + Demonstrated ability to mentor and coach with the ability to motivate teams to reach a common goal + Proficient in Microsoft Excel, Word, PowerPoint + Ability to read, analyze and interpret professional journals, technical procedures, and governmental regulations + Strong written and verbal communication and presentation skills including the ability to independently write and develop standards and procedures + Ability to solve problems with a variety of variables using past experience + Ability to interpret instructions furnished in written, oral, diagram, or schedule form Supervisory responsibilities This position does not have supervisory responsibilities. Physical requirements 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 is regularly required to sit; use hands to manipulate, handle, and feel; and able talk and hear. The employee frequently is required to reach with hands and arms. The employee is required to stand; walk; and occasionally required to climb or balance. The employee must occasionally lift and/or move up to 10 pounds. Work environment 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 is occasionally exposed to moving mechanical parts. The noise level in the work environment is usually quiet. The above statements are intended to describe the general nature and level of work performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all job duties performed by the personnel as classified. Management reserves the right to revise or amend duties at any time.

Pay Range:

$171,000-$220,000 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.