Job Description
US Regional Director, Quality Operations Support - Remote (East Coast)
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.
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: $196,800-$237,100/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.
All interested applicants must apply online. Please be aware of scammers. Curia will only send offer letters and requests for sensitive personal information from a curiaglobal.com email address.
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