Shift Available:
- Wednesday–Saturday, onsite night shift, 6:00 p.m.–4:30 a.m.
Responsibilities:
- Implement and manage Label Operations at BMS S12 Summit West (Summit, NJ) per BMS policies, standards, procedures, and Global cGMPs.
- Supervise all label control activities for CTDO; develop/maintain GMP-compliant clinical and commercial label issuance/control processes.
- Lead and oversee daily Label Operations team activities; coordinate/prioritize deliverables for launches and quality activities.
- Ensure timely issuance of in-process and final product labels; maintain compliance and proactively address label control issues.
- Serve as site lead for clinical/commercial label management system implementation projects within timelines.
- Write/review/update SOPs; manage archival of batch records and GMP documentation.
- Perform gap assessments; develop/maintain quality metrics; collaborate to resolve quality system issues.
- Onboard requirements for new label control staff; coach/mentor subordinates; develop employee plans.
- Maintain cGMP/global regulatory knowledge; perform supplemental investigations/projects as needed.
Minimum Requirements:
- B.S. degree (or equivalent education/experience).
- 5+ years relevant experience.
- 2+ years leadership experience.
Required Skills/Knowledge:
- Advanced GMP/quality/compliance/risk management; strong communication and authorship/review of reports.
- Decision-making, problem solving, planning/organizing, conflict management, and analytical thinking.
- PC-based proficiency and Microsoft Office.
Benefits (if applicable/eligible):
- Health coverage; wellbeing support; 401(k) and life/disability insurance.
- Paid time off; 11 paid national holidays (role/plan dependent).
Working Conditions:
- Typical office environment; seated most of the time; may stand/walk up to ~10% of time.