Site Quality Head
Curia
Summary
The Site Quality Head is directly responsible for oversight of total quality and compliance operations at the assigned site. This role uses leadership and experience to instill the highest caliber of operational excellence and guides department leadership teams in the execution of quality goals, with a focus on continuous improvement, high-quality standards, and the best-in-class customer satisfaction.
Job description
The Site Quality Head works closely with global teams in developing, implementing and maintaining corporate quality standards, policies, procedures, and processes, and control tests ensuring that the quality in site operations meet all legal, corporate, and FDA quality requirements.
Responsibilities
- Supervise, coach and develop Quality staff
- Oversee day-to-day operations for Quality Systems
- Collaborate with others to avoid potential obstacles and to resolve exceptions and/or deviations resulting from process, equipment, or environmental excursions
- Ensure that all exception reports are triaged, investigated, and resolved with the appropriate CAPAs within clearly defined timeframes
- Oversee Validation, Change Control, Work Orders, training, planned deviations and Environmental Monitoring activities as they apply to manufacturing operations
- Own change requests
- Develop, write, review and/or approve Change Controls, protocols, summary reports, memorandums, action plans, etc., and oversee training and execution of related activities
- Ensure business process needs and deliverables are met and that the group’s routine business process functions are executed in conjunction with Curia policies and cGMP
Qualifications
- Bachelor’s degree in science or a relevant field and a minimum of 10 years of relevant related work experience in aseptic production/processing cleaning practices within a regulatory environment, plus 5 years in professional management role
- Ability to create and maintain strong working relationships with multiple organizations, both on-site and externally
- Ability to enable and empower managers and hold them accountable for results
- Ability to provide strategic leadership to the organization in terms of strategy development, and provide resources and execution of defined strategy
- Ability to read, analyze and interpret financial reports, common scientific and technical journals and legal documents
- Ability to respond to common inquiries or complaints from customers, regulatory agencies or members of the business community
- Ability to effectively present information to all levels throughout the organization, government agencies, boards of directors and customers
Other Qualifications
- Must pass a background check
- Must pass a drug screen
- May be required to pass Occupational Health Screening
Requirements
- Bachelor’s degree in science or a relevant field
- Minimum of 10 years of relevant related work experience in aseptic production/processing cleaning practices within a regulatory environment
- 5 years in professional management role
- Ability to create and maintain strong working relationships with multiple organizations, both on-site and externally
- Ability to enable and empower managers and hold them accountable for results
- Ability to provide strategic leadership to the organization in terms of strategy development, and provide resources and execution of defined strategy
- Ability to read, analyze and interpret financial reports, common scientific and technical journals and legal documents
- Ability to respond to common inquiries or complaints from customers, regulatory agencies or members of the business community
- Ability to effectively present information to all levels throughout the organization, government agencies, boards of directors and customers
- Must pass a background check
- Must pass a drug screen
- May be required to pass Occupational Health Screening
Benefits
- Generous benefit options
- Paid training
- Paid vacation
- Paid holidays
- Career advancement opportunities
- Education reimbursement
- 401(k) Matching
- Learning platform
Company overview
Curia is a leading global Contract Development and Manufacturing Organization (CDMO) with over 30 years of experience in the pharmaceutical industry. Headquartered in Albany, New York, the company operates an integrated network of 25 global sites across North America, Europe, and Asia, employing approximately 3,500 professionals. Curia provides comprehensive end-to-end solutions spanning drug discovery, development, and manufacturing services for both small molecules and biologics. Their expertise covers active pharmaceutical ingredient (API) manufacturing, sterile drug product development, analytical testing, and regulatory support. The company specializes in complex areas including high-potency compounds, controlled substances, sterile APIs, and mRNA manufacturing. With state-of-the-art GMP facilities and a strong focus on innovation, Curia partners with pharmaceutical and biotechnology companies to accelerate the development and commercialization of life-changing therapeutics, from early-stage discovery through commercial-scale production.