20 days old

Sr. Operations Manager

Kelly Services
Bedford, OH 44146
**Sr. Manager, Sterile Operations**

Kelly is looking for a Sr. Operations Manager for a very reputable Pharmaceutical manufacturer. This position offers full benefits and a relocation package is available for the right candidate.

**Job Description:** The Senior Manager of Sterile Operations will be responsible for all operations and maintenance functions for Line 7 to included, but not limited to the following:

+ Components Preparation, Compounding, Filling, Lyophilization, Capping, Operations Support, and Production Maintenance .

+ The Senior Manager will ensure all activities within the operations department are executed in CGMP complaint manner and comply with all applicable regulations.

+ This role will establish systems that support that procedures are continuously improved to heighten quality. Ensure adherence to the production plan and delivery of on time and in full targets by having stable processes with minimal variation.

+ Develop direct reports competences and skills, manage, lead and motivate the sterile operations team in an empathetic and trusting manner.

**Key Responsibilities:**

+ Proactively and continuously manage product risk and escalate risks through site management and the global organization as necessary

+ Implement and conceive operational strategy to optimize process, production and maintenance systems for continuous performance improvement in safety, quality, cost, and schedule adherence

+ Ensure that systematic problem solving happens on the shop floor where all relevant stakeholders are involved Share knowledge with other sites to ensure consistency of approach and sharing of best practices

+ Develop, manage and control spending for the department. Support LTP Budget through scenario development and capacity utilization studies

+ Have clearly defined roles and responsibility, so tasks, responsibilities and decision competencies are well understood by all department members

+ Be present on shop floor to conduct coaching of leaders and exchange process knowledge Ensure all supervised personnel are adequately trained and perform job function or work tasks assigned

+ Do daily process confirmation of team leader tasks to ensure correct use of performance boards, systematic problem solving, and process confirmation of procedures related to operators, mechanics and others

+ Ensure that all KPIs are visible, understandable and relevant for team and supervisors, and that the individual team member is aware of how to affect relevant KPIs Attract, retain and develop staff with the appropriate behaviors and commitment Conduct PMP, interviews, VoW and other activities according to the standard

+ Work closely together with quality to solve quality issues as they occur and ensure timely release of products Ensure quick implementation of effective containments and countermeasures

+ Abide by the rules and regulations regarding environmental requirements Ensure processes and products are in compliance with all local, state, and federal rules and regulations. Oversee that processes are in CGMP compliance and establish systems that identifies opportunities for improvement and makes constructive suggestions for change to improve process effectiveness to heighten quality.

+ Develop knowledge of and understand regulatory requirements such as 21CFR Parts 210 and 211, cGMPs, FDA, OSHA and other regulatory agencies.



+ 6+ years of combined applicable experience (pharma or similar manufacturing /regulated environment)

+ Prior experience managing sterile bulk, aseptic/TS filling, or similar production operations


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.

**Why Kelly** **** **Science & Clinical?**

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the worlds most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goalsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kellys Human Resource Knowledge Center.
Kelly complies with the requirements of Californias state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.
Posted: 2022-09-16 Expires: 2022-10-17

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Sr. Operations Manager

Kelly Services
Bedford, OH 44146

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