Site Quality Head

Curia Aalborg ApS; Hopkinton (MA); On-site; USD 206,000 - 251,000; Full time

Benefits offered by this job

Generous benefit options (eligible on

Paid training, vacation and holidays

Career advancement opportunities

Education reimbursement

401K program with matching

Learning platform

And more!

Job summary

Curia is seeking a Site Quality Head in Hopkinton, MA to lead quality systems, compliance and continuous improvement at the site level. You will guide senior quality leaders, ensure FDA and cGMP compliance, and drive proactive CAPA execution while partnering with global teams.

The role demands a bachelor’s degree in science, 10+ years in aseptic production and 5+ years in management, with strong leadership, strategic thinking and cross-functional collaboration to sustain best-in-class quality

Qualifications

• Bachelor's degree in science or relevant field and at least 10 years in aseptic production with 5 years in management.
• Ability to build relationships across organizations and sites.
• Strategic leadership and execution of quality programs.

Responsibilities

• Oversee day-to-day Quality Systems operations.
• Lead and develop the Quality staff through coaching.
• Collaborate with global teams to enforce quality standards and regulatory compliance.
• Ensure CAPAs are implemented within defined timeframes.
• Oversee change controls, validation, and environmental monitoring in manufacturing.
• Own change requests and related documentation.
• Ensure processes meet cGMP and Curia policies.

Skills

Leadership

Relationship building

Strategic leadership

Regulatory understanding

Financial interpretation

Communication across levels

Education

Bachelor's degree in science or relevant field

Job description

Site Quality Head in Hopkinton, MA

Build your future at Curia, where our work has the power to save lives.

Job Description

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.

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.

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
• And more!

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

Pay Range: $206,080-$251,275/year

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

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.