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Manager, Global Quality Systems and Business Process Owner (Remote)

Curia provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries.

Join our talented workforce, where a commitment to excellence and a customer focused attitude is everything. We pursue excellence because our work has the power to improve patients’ lives with the pharmaceuticals we develop and manufacture.

Summary:

This role will effectively collaborate with cross-functional technical and operational teams across the sites and global functions to support the implementation and maintenance of the Global Quality Management System for GxP elements of the business. The role includes the implementation of electronic systems that align with ICH Q10 and all applicable regulatory guidance. Strong technical and leadership experience, in a functional and cross-functional matrix, are critical to the successful execution of the roles and responsibilities of this role.

Responsibilities (includes the following. Other duties may be assigned):

• Lead/partner with IT and CSV on the implementation and validation of electronic solutions (specifically LIMS, LMS, and QMS) in alignment with the Global Quality strategy.

• Verify the effectiveness of Quality Systems through audits of Deviation/CAPA/CR reviews

• Lead continuous improvement of Quality Systems, such as CAPA, Deviation, Investigation, and Change Management, and direct the efforts to develop, implement, and maintain compliant and effective Quality Systems

• Responsible for developing various training programs by collaborating with the global compliance team and site teams

Qualifications:

• B.S./B.A. or M.S. degree in Chemistry, Microbiology, or related field.

• Minimum of 5 years QC / Quality experience in the pharmaceutical or biotechnology industry.

• Experience in Quality Systems, with LIMS experience is a must. LabVantage experience is preferred.

• Hands-on experience with developing, implementing, validating, and managing electronic systems (e.g., LIMS, QMS).

• Demonstrated leadership experience, both functional and cross-functional (e.g., project management, cross-functional teams, etc.).

• Strong knowledge of regulatory requirements (21 CFR Parts 11, 210, 211, 820).

• Strong change management/ implementation experience.

• Minimum 2 years of managing quality laboratory systems (LIMS, ELN) in a global, multi-site, environment.

• Excellent communication, time management, and organizational skills.

• Experience working in a high-level collaborative environment and promoting a teamwork mentality.

Pay Range:

$105,000 - $131,000

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

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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