Site Quality Head

Curia; City of Rensselaer (NY); On-site; USD 170,000 - 225,000; Full time

Benefits offered by this job

Generous benefit options

Paid training, vacation and holidays

Career advancement opportunities

Education reimbursement

401K program with matching contributions

Learning platform

Job summary

Curia is seeking a Site Quality Head in Rensselaer, NY to lead Quality Assurance efforts in Pharmaceutical Manufacturing. The role demands a Bachelor's degree in a relevant field and at least 10 years of experience, including 5 years in a leadership capacity. Key responsibilities include ensuring GMP compliance, managing Quality Systems, and supervising staff. The position offers a competitive salary range of $170,000 to $225,000, alongside generous benefits including education reimbursement and career advancement opportunities.

Qualifications

• Minimum 10 years’ experience in Pharmaceutical Manufacturing.
• 5 years in a leadership role within regulatory environments.

Responsibilities

• Provide technical and quality oversight to the VP of Quality Operations.
• Ensure GMP compliance across manufacturing operations.
• Drive site inspection readiness program and risk assessment.

Skills

Quality System remediation

Strong communication skills

Leadership skills

Strategic leadership

Education

Bachelor's degree in Science, Chemical Engineering or related field

Job description

Site Quality Head – Rensselaer, NY

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. We are on a mission to advance our customers’ therapies from curiosity to cure and ultimately to improve patients’ lives.

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!

Essential Job Duties

• Site Head of Quality 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 and is responsible for all aspects of GMP compliance from material dispensing to final product dispatch.
• Provides guidance and processes that comply with global cross‑contamination control requirements.
• Provides oversight and direction to the QC laboratories.
• Supports plant management groups on new products, changes to products, processes, and services to achieve a consistent approach to Quality Assurance and Regulatory Affairs.
• Drives robust site inspection readiness program, assesses risks and provides guidance on compliant mitigation actions.
• Directs quality and compliance process improvements and goals for the site using current regulations and demonstrated best practices.
• Supports effective and efficient continuous quality and cost improvement efforts.
• Ensures requirements of Curia global Quality Systems are implemented and maintained in each operation throughout the facility.
• Drives accountability for all decisions made affecting product and process quality.
• Evaluates and recommends solutions and implementation strategies for product/process issues through use of analytical, technical and leadership skills.
• Contributes to core values of Quality, Timeliness, Communication and Profitability.
• Directs and manages the Manufacturing Quality Assurance, validations and investigations.
• Directs and manages the Quality Systems function.
• Drives improvements to Quality performance metrics.
• Sets and oversees data integrity standards at the site.
• Coordinates lot release, investigations, and customer relationships.
• Provides plant management with data and information to reduce potential for regulatory action and assists in site productivity management.
• Develops and maintains the Quality budget on site.

Supervisory Responsibilities

This position supervises staff.

Required Qualifications

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

Knowledge, Skills and Abilities

• 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.
• Strong, effective leadership skills.
• Ability to enable and empower managers and hold them accountable for results.
• Ability to create a climate of trust and cooperation.
• Exhibits 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.
• 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.

Pay Range

$170,000 – $225,000.

Equal Opportunity Employer

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 based on disability. Curia is an E‑Verify employer.