Manager, Operations

Operations Manager

The Operations Manager oversees the scheduling and execution of all phases of clinical packaging, labeling, manufacturing, and assembly of investigation drug product that includes but is not limited to blistering, bottling, carding, encapsulation, manufacturing, labeling, and assembly. This role ensures quality, customer satisfaction, and completion of packaging within the timelines negotiated with Project Management. This position ensures the department remains in compliance with all company SOPs, cGMP regulations, and safety requirements. The Production Manager leads and develops two direct reports and supports a culture of continuous improvement and accountability.

Essential Duties and Responsibilities

• Manage and oversee the execution of packaging of Production operations in accordance with company SOPs and cGMP Regulations.
• Create, maintain and review production operation key performance indicators.
• Manage and oversee the creation and maintenance of the production schedule.
• Evaluate the layout, staffing, and equipment usage and make improvements as needed.
• Lead, coach, and develop direct reports and their respective teams, fostering a culture of performance, accountability and continuous improvement.
• Build team capability by identifying training needs and supporting cross-training and succession planning initiatives.
• Review production client proposals to ensure accuracy.
• Improve production processes via continuous improvement strategies.
• Collaborate with internal departments and external sources to resolve issues with Logistics operations relating to projects and expectations.
• Develop the Production team so that they are experts in the operation.
• Document performance reviews for the Production team.
• Conduct and review investigations, complaints and deviations. Implement improvements based on root cause analysis.
• Collaborates with internal departments and external sources to resolve issues with Production relating to projects and expectations.
• Maintain, enforce and adhere to company policies to provide security and a safe environment for all personnel and facility.
• Participates in audits and investigations and recommends viable solutions.
• Ensure all GMP operational departments are compliant with cGMPs and SOPs.
• Assist Project Management department in reviewing pre use batch records.
• Other duties as assigned.
• Must be flexible to meet the needs to the organization relative to off shift operations when required.
• Adhere to policies, processes and SOPs to ensure compliance with cGMP, FDA and any other regulatory regulations and safety standards.
• Participate actively in regular meetings.
• Achieve expected performance measures.
• Other duties as assigned

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.