Note: The job is a remote job and is open to candidates in USA. Curia is a global contract development and manufacturing organization dedicated to providing life-saving treatments. The Director of Quality Operations Support is responsible for enabling the Business Unit Quality Head and supporting site Quality Heads in implementing quality standards and managing quality operations, including preparation for regulatory inspections and audits.
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
- 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
- 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
- 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
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
Company Overview