Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
We are PCI.
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
Main purpose of job:
• The role is responsible for the operations performance (Safety, Quality, Delivery and Cost) of a set value stream in the packaging area.
• The VSM will provide leadership, set direction, provide performance management and coordinate required resources to complete monthly schedules in a cGMP compliant environment.
• Additionally, this role will collaborate closely with Stakeholders across Engineering, Supply Chain, NPI, Key Account Management and Finance to design and optimize our value streams to support business objectives. This will be a client facing role.
Responsibilities:
• Ensure compliance with relevant safety and cGMP regulations and adherence to Company policies across all production activities, fostering a culture of safety, compliance and efficiency.
• Lead the establishment and ongoing enhancement of best practices and operational solutions, driving Operational Excellence and service quality across the value stream.
• Manage all operational aspects of their area of responsibility and align materials, quality, engineering, production and customer service functions to establish reliable processes that improve safety, quality, schedule and cost performance. Specifically, work with the Planning, Warehouse & QA teams to ensure production kits are available OTIF.
• Support the QMS function in dealing with customer complaints, ensuring thorough investigations are conducted and effective CAPAs are put in place.
• Be the Production point of contacts for the NPI team and respective clients in the running of trials and PVs for new products on existing and new packing lines.
• Ensure the production area is maintained in an audit ready state for both customer and regulatory inspections and act as SME for all visits.
• Ensure clear and accurate communication of current production status to all relevant departments through the appropriate meetings / updates.
• Spearhead continuous improvement and innovation initiatives within their areas of responsibility to reduce cycle time, increase throughput and minimize changeover losses to increase internal capacity.
• Establish and utilize metrics to drive improvement activity and ensure that decisions are based on facts and measurement trends.
• Interface with customer as required in a professional manner to ensure customer satisfaction
• Coordinate with other VSMs to manage daily headcount and balance production and customer needs to manage costs and create reliable processes.
• Provide leadership and motivation to maximize team effectiveness, clearly communicating tasks and goals to the team.
• Support Senior Production Supervisors in the management and development of employees in the VSM's area of responsibility to include necessary recruitment, training, employee relations, reward and recognition with support from Human Resources.
• Carry out various other additional tasks that may be required from time to time in accordance with the overall goal of the company. Knowledge / Skills & Experience Essential:
• Degree/diploma qualified in a science/engineering/manufacturing discipline. May substitute experience in lieu of education.
• Min 5 years' manufacturing experience in a GMP or Regulated Environment.
• Min 2 years' experience of people-management.
• Strong knowledge of production & quality systems.
• Experience in Lean Manufacturing, including experience in Lean tools to develop continuous improvements.
• Ability to manage multiple tasks and set priorities.
• Problem Solving and Troubleshooting skills. The successful candidate should display a dynamic and proactive approach to manage production issues.
• Self-motivated with a results driven approach.
• Flexibility to work across different shifts on request in line with business needs.
• Adaptable and ability to work collaboratively.
• Strong organizational, communication, and leadership skills.
• Ability to work cross-functionally and influence stakeholders at all levels.
• High level of integrity.
• Proficient in Microsoft Office products (incl. Excel, PowerPoint, Word, etc.) Desirable:
• Project Management experience.
• Experience with JDE or other MES systems.
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Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.