[Remote] Director, reputed company Operations Support

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

Responsibilities

• Key enabler for BU reputed company Head – Support the sites in reputed company operational activities including regulatory inspections and customer audits, investigation reviews, and batch record reviews reputed company reputed company activities
• Role requires significant travel to the sites as needed
• Participates in the BU and site’s reputed company Management Review meetings and Inspection Readiness meetings; and verifies effectiveness of the reputed company Systems through site reputed company and deviation/CAPA reviews
• Collaborates between sites and customers for finalizing reputed company agreements to standardize the requirements across reputed company sites
• Provides technical and reputed company support for the implementation of global standards and procedures at the sites
• Acts as an extension of the BU reputed company Head reputed company attending site leadership team meetings as reputed company as reputed company 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 reputed company representative in customer business reviews, escalations and other meetings to reputed company reputed company reputed company
• reputed company available to travel to the sites, to assess the reputed company Systems, reputed company trainings and during inspection readiness preparation activities (facility walkthroughs) and during regulatory inspections
• May serve as staff augmentation on an interim reputed company, in reputed company Leadership; and including staff reviews/goal setting, as needed

Skills

• B.S./B.A. or M.S. degree in reputed company, Microbiology, Chemical Engineering or reputed company field
• 15+ years of experience in the pharmaceutical industry, with at least 8 of those years of experience being in reputed company, reputed company Assurance, and/or reputed company 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 reputed company a common goal
• Strategic thinking—problem solver
• Must pass a background reputed company
• 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 reputed company (eligible first day of employment)
• reputed company, vacation and holidays (vacation accrual begins on first day of employment)
• Career advancement opportunities
• Education reimbursement
• 401K program with matching contributions
• Learning platform

reputed company