Senior Manager, Operations

The Senior Manager, Operations is a strategic leader responsible for overseeing the end-to-end execution of clinical and commercial packaging, labeling, manufacturing, and assembly of investigational drug products. This includes blistering, bottling, carding, encapsulation, and related operations. This role ensures operational excellence, regulatory compliance, and customer satisfaction, while driving continuous improvement and innovation across the department. The Operations Manager leads a high-performing team, fosters a culture of accountability, and partners cross-functionally to meet project timelines and quality standards.

Essential Duties and Responsibilities

• Lead and oversee all aspects of clinical and commercial packaging operations, ensuring alignment with company SOPs, cGMP regulations, and industry best practices.
• Develop, monitor, and optimize key performance indicators (KPIs) to drive operational efficiency, quality, and customer satisfaction.
• Own the production schedule, balancing resource allocation, capacity planning, and client timelines to ensure on-time delivery.
• Assess and enhance facility layout, workforce planning, and equipment utilization to support scalability and continuous improvement.
• Inspire and develop high-performing teams through coaching, performance management, and leadership development initiatives.
• Strengthen team capabilities by identifying skill gaps, implementing targeted training programs, and supporting cross-training and succession planning.
• Champion continuous improvement, leveraging Lean, Six Sigma, or other methodologies to streamline processes and reduce waste.
• Collaborate cross-functionally with Logistics, Quality, Project Management, and external partners to proactively resolve operational challenges.
• Conduct and document performance evaluations, providing actionable feedback and development plans.
• Lead investigations into deviations, complaints, and non-conformances, applying root cause analysis and implementing corrective/preventive actions.
• Promote a safe and secure work environment, enforcing company policies and safety protocols.
• Participate in audits and client visits, representing the department and driving resolution of findings.

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty. The minimum requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Previous production manager or senior supervisory experience required.
• 5+ years of previous experience in clinical and/or commercial packaging, with at least 3 years in a supervisory or managerial capacity.
• Bachelor's Degree or equivalent experience, preferably in clinical supplies packaging or cGMP environment.
• Strong leadership to mentor and develop team to achieve Company goals.
• Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
• Excellent oral and written communication is required to communicate with the team, peers, management and external contacts.  Ability to speak effectively before a group of any combination of the above.
• Working knowledge of personal computers and Microsoft Office Products, including Word, Project and Excel.
• Must have the ability to work in a cross-functional team environment.
• Excellent oral and written communication skills to communicate with the team, peers, management, and external contacts.
• Working knowledge of personal computers and Microsoft Office Products, including Word, Project, and Excel.
• Proficient with interpreting and implementing cGMP, FDA, DEA, and OSHA regulations.
• Strong leadership skills to mentor and develop team to achieve company goals.