US Regional Director, Quality Operations Support

Curia; United States; On-site; USD 148,000 - 184,700; Full time

Benefits offered by this job

Generous benefits

Paid training

Vacation and holidays

401K matching

Education reimbursement

Learning platform

Career advancement

Job summary

Curia seeks a Director of Quality Operations Support to enable the BU Quality Head for API and Biologics, driving inspection readiness and robust quality systems across sites. This role acts as a delegate in customer and internal meetings and supports complex investigations.

The position requires leading quality operations, mentoring teams, and implementing global standards while traveling to sites as needed to ensure compliance and strategic quality objectives are met.

Qualifications

• Bachelor’s degree (B.S./B.A. or M.S.) in Chemistry, Microbiology, Chemical Engineering or related field.
• 15+ years pharma experience, with 8+ years in Quality/QA/Quality Systems/Compliance and at least 5 years supervisory.
• Experience in small molecule API and/or Biologics manufacturing; strong regulatory knowledge.

Responsibilities

• Enable BU Quality Head for API and Biologics in delivering strategic quality objectives.
• Provide onsite support for inspection readiness, regulatory inspections, and customer audits.
• Lead and participate in quality reviews, deviation/CAPA management, and Quality Systems oversight across sites.
• Coordinate training, qualification programs, and implementation of global standards and procedures.
• Travel to sites as needed to support quality operations and leadership activities.

Skills

Leadership

Quality Systems

Regulatory Knowledge

QA/Quality Assurance

Mentoring

Strategic Thinking

Travel Readiness

Audit Readiness

Education

Bachelor’s/Master’s in Chemistry/Biology/Engineering

Job description

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

Job Description

The Director of Quality Operations Support is responsible to enable the Business Unit (BU) Quality Head for API (Small Molecule and Generic APIs) and Biologics, in delivering Curia’s strategic objectives. This position also enables the site Quality Heads in the effective implementation of global quality standards, global procedures, and other strategic initiatives. The Director of Quality Operations Support is responsible for providing onsite support to the sites for inspection readiness, during regulatory agency inspections or customer audits, managing day to day quality operations, and as a subject matter expert for complex investigations. This role also serves as a delegate for BU Quality Head in customer and internal meetings.

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

• Key enabler for BU Quality Head – Support the sites in quality operational activities including regulatory inspections and customer audits, investigation reviews, and batch record reviews related oversight activities
• Role requires significant travel to the sites as needed
• Participates in the BU and site’s Quality Management Review meetings and Inspection Readiness meetings; and verifies effectiveness of the Quality Systems through site visits and deviation/CAPA reviews
• Collaborates between sites and customers for finalizing quality agreements to standardize the requirements across all sites
• Provides technical and quality support for the implementation of global standards and procedures at the sites
• Acts as an extension of the BU Quality Head when attending site leadership team meetings as well as quality team meetings
• Develops and delivers various training to the sites to emphasize compliance to site and global procedures. Trainings also include leading qualification programs (e.g., Investigations) at the sites
• Provides technical support as required for the implementation of electronic systems such as DMS and LIMS at the sites
• Participates in the development of responses at the sites to address regulatory inspection findings
• Facilitates and reviews gap assessments performed by the sites for inspectional findings across the network; and to corporate procedures and standards. Supports the sites in meeting requirements, as needed
• Plays a key role as above site Quality representative in customer business reviews, escalations and other meetings to drive Quality decisions
• Readily available to travel to the sites, to assess the Quality Systems, provide trainings and during inspection readiness preparation activities (facility walkthroughs) and during regulatory inspections
• May serve as staff augmentation on an interim basis, in Quality Leadership; and including staff reviews/goal setting, as needed.

Required

• B.S./B.A. or M.S. degree in Chemistry, Microbiology, Chemical Engineering or related field
• 15+ years of experience in the pharmaceutical industry, with at least 8 of those years of experience being in Quality, Quality Assurance, and/or Quality Systems/Compliance, and at least 5 of supervisory experience
• Experience in small molecule API manufacturing and/or Biologics drug substances manufacturing
• Strong knowledge of the pharmaceutical industry regulations applicable to API and Biologic manufacturers
• Demonstrated experience in mentoring and coaching, with ability to motivate teams to reach a common goal
• Strategic thinking—problem solver

Other Qualifications

• Must pass a background check
• Must pass a drug screen
• May be required to pass Occupational Health Screening
• May be required to obtain and maintain gowning certification
• May be required to obtain and maintain media qualification

Pay Range: $148,000-$184,700/year

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

We do not accept unsolicited assistance from any headhunters or recruitment firms for any of our job openings. All resumes or profiles submitted by search firms to any employee at Curia, in any form without a valid, signed search agreement by an authorized signatory in place for the specific position, approved by Talent Acquisition, will be deemed the sole property of Curia. No fee will be paid in the event the candidate is hired by Curia because of the unsolicited referral.

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.