Site Quality Head

About the role

The Site Quality Head at Curia is responsible for overseeing quality standards, policies, procedures, and processes to ensure compliance with legal, corporate, and FDA quality requirements. This role involves providing technical and quality oversight, ensuring GMP compliance, and driving continuous quality and cost improvement efforts.

Responsibilities

• Provides technical, quality oversight and support to the VP of Quality Operations in making quality decisions
• Ensures adequate manufacturing quality oversight across manufacturing and packaging operations
• Responsible for all aspects of GMP compliance, including quality oversight from material dispensing to final product dispatch
• Guides and implements processes to comply with global cross-contamination control requirements
• Oversees and directs QC laboratories
• Supports plant management groups on new products, changes to products, processes, and services
• Drives robust site inspection readiness programs, assesses risks, and provides compliant mitigation guidance
• Manages quality and compliance process improvements and goals using current regulations and best practices
• Ensures implementation and maintenance of Curia's global Quality Systems in all operations
• Evaluates and recommends solutions for product and process issues
• Contributes to the organization's strategy development and provides resources and execution of defined strategy
• Coordinates lot release and investigations, and maintains customer relationships
• Keeps plant management informed about compliance commitments and assists in productivity management
• Supervises staff and manages the Manufacturing Quality Assurance, validations, and investigations functions
• Directs and oversees Quality Systems function, driving improvements to quality performance metrics
• Develops and maintains Quality budget on site

Requirements

• Bachelor’s degree in Science, Chemical Engineering, or related field
• At least 10 years of experience in Pharmaceutical Manufacturing, preferably with Drug Substance commercial manufacturing facility within a regulatory environment
• At least 5 years of experience in a leadership role

Qualifications

• Quality System remediation and transformation experience in API or DP manufacturing facility
• Strong verbal and written communication skills
• Strong knowledge of business process needs of quality assurance
• Ability to create and maintain strong working relationships with multiple organizations, both on-site and externally
• Effective leadership skills
• Ability to enable and empower managers and hold them accountable for results
• Ability to create a climate of trust and cooperation
• Strong adherence to personal and company values
• Ability to provide strategic leadership to the organization in terms of strategy development, and provide resources and execution of defined strategy
• Reads, analyzes, and interprets financial reports, common scientific and technical journals, and legal documents
• Responds to common inquiries or complaints from customers, regulatory agencies, or members of the business community
• Effectively presents information to all levels throughout the organization, government agencies, boards of directors, and customers

Skills and Abilities

• Knowledge of business process needs of quality assurance
• Strong verbal and written communication skills
• Strong knowledge of business process needs of quality assurance
• Ability to create and maintain strong working relationships with multiple organizations, both on-site and externally
• Effective leadership skills
• Ability to enable and empower managers and hold them accountable for results
• Ability to create a climate of trust and cooperation
• Strong adherence to personal and company values
• Ability to provide strategic leadership to the organization in terms of strategy development, and provide resources and execution of defined strategy
• Reads, analyzes, and interprets financial reports, common scientific and technical journals, and legal documents
• Responds to common inquiries or complaints from customers, regulatory agencies, or members of the business community
• Effectively presents information to all levels throughout the organization, government agencies, boards of directors, and customers

Benefits

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!

Pay

Pay Range: $170,000 - $225,000

Schedule

N/A

Location

Rensselaer, NY