Remote US Regional Director, Quality Operations

Curia, Inc.; United States; Remote; USD 197,000 - 237,000; Full time

Benefits offered by this job

Generous benefit options (eligible 1st

Paid training, vacation and holidays (

Career advancement opportunities

Education reimbursement

401K program with matching contributes

Learning platform

And more!

Job summary

Curia seeks a US Regional Director, Quality Operations Support (Remote - East Coast) to enable the BU Quality Head for API and Biologics and drive global quality standards, procedures, and strategic initiatives.

You will provide onsite support for inspections, audits, and investigations, manage day-to-day quality operations, mentor teams, and travel to sites as needed. This role acts as an extension of the BU Quality Head in leadership and cross-site quality reviews.

Qualifications

• 15+ years of pharmaceutical industry experience with at least 8 years in Quality, Quality Assurance, and/or Quality Systems/Compliance, and at least 5 years 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.

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.

Skills

Leadership

Mentoring

Regulatory knowledge

Strategic thinking

Travel readiness

Education

B.S./B.A. or M.S. degree in Chemistry, Microbiology, Chemical Engineering or related field

Job description

Curia seeks a US Regional Director, Quality Operations Support (Remote - East Coast) to enable the BU Quality Head for API and Biologics and drive global quality standards, procedures, and strategic initiatives.

You will provide onsite support for inspections, audits, and investigations, manage day-to-day quality operations, mentor teams, and travel to sites as needed. This role acts as an extension of the BU Quality Head in leadership and cross-site quality reviews.