Bioprocessing Specialist & Permanent Inspection Read Lead Supply Chain

Bioprocessing Specialist & Permanent Inspection Read Lead Supply Chain

BioMarin

Cork, Ireland

SUMMARY DESCRIPTION

The overall Supply Chain Operations (SCO) department is responsible for the site planning & scheduling, Raw Materials Purchasing, Oracle recipe management, VMI (Vendor Managed Inventory), Materials management, Warehouse, Dispensing/Sampling and Shipping to customers.

Reporting to the Supply Chain Operations Manager of the functional area, the primary role of the SCO BPS & PIR Lead is to provide SCO technical leadership and lead permanent inspection readiness within SCO. The lead will be committed to team development, continuous improvement and compliance. A high level of initiative, influencing and questioning skills are key role requirements, as well as excellent organisational skills.

Main areas of responsibility

Compliance Leadership:

• Lead, own, investigate, write and approve investigations and CAPA implementation on site QMS system
• Participate in cross-functional teams, as applicable, to troubleshoot and resolve technical issues using root cause analysis tools
• Develop, define scope, and support the implementation of technical solutions under the guidance of site change control systems
• Develop and demonstrate an active approach to safety, industrial hygiene, environmental and regulatory compliance
• Ensure areas meet compliance standards and highlight any issues and work proactively with the area team and others to ensure resolution
• Partner with validation subject matter experts, prepare/approve validation protocols, validation plans, protocol executions, and summary reports in support of ongoing revalidation and validation efforts required for commercial manufacturing
• Provide guidance on compliance and regulations and build competency within the Supply Chain Operations (SCO) team
• Develop and maintain an internal compliance programme within SCO
• Anticipate questions and focus areas related to ICH and Annex 1 guidelines
• Foster high expectations and unrelenting persistence towards continued audit success
• Generate responses to audit findings
• Lead and participate in self-inspections and compliance walk-throughs of all SCO areas
• Demonstrate a strong task focus. Use data analysis to identify problem areas and drive implementation of improvements and initiatives.
• Liaise with site and global support teams to share learnings and implement improvements at a company wide scale
• Responsible for reporting, monitoring and improving compliance metrics for SCO team
• Demonstrate a quality focused approach to decisions in SCO. Consider site wide impact and solutions to issues/decisions
• Use risk assessment and problem-solving tools to contribute to quality / compliance-related investigations / continuous improvements initiatives

Team Leadership:

• Foster a safety and quality focused environment through inspection readiness coaching support
• Coach, mentor and train team members on area processes, procedures, use of operational excellence tools, and high-performance team behaviours
• Supervise, and perform as needed, employee training in SCO
• Effectively and consistently prioritise and delegate daily assignments and projects to technicians and associates. Ensure that all staff understand, properly prioritize, and execute their assignments and adhere to production schedule
• Report, monitor and improve compliance metrics within SCO
• Lead effective documentation lifecycle management for SCO
• Lead preparation for regulatory and corporate audits
• Create a permanent audit readiness state and a zero-late mindset
• Implementation of projects and initiatives to improve compliance metrics and audit preparedness
• Develop effective working relationships with key stakeholders across site

Skills

• Demonstrated experience working with MFG processes, device assembly and secondary packaging operations in a cGMP environment
• Past experience and demonstrated ability to successfully influence team performance in a high performance team is preferred
• Demonstrate strong communication skills and the ability to interact across cross-functional teams
• Track record of embedding a strong Quality and Safety culture
• Strong process knowledge of quality systems
• Excellent project management skills
• Proven ability to lead and deliver on multiple and agile and flexible to work on multiple initiatives
• Strong continuous improvement focus
• Strong collaboration skills
• Experience with site regulatory inspections and direct interaction with regulatory inspectors
• Highly developed organizational and leadership skills

Equipment

• Should be proficient in the operation of all equipment used in the respective functional area of responsibility.

Education

• Bachelor degree in biotechnology, chemical or biochemical engineering, biochemistry or bio-systems engineering or related field or equivalent experience in a GMP environment is preferred.
• Other continuing education initiatives highly desirable (e.g. Six Sigma, Lean Manufacturing, industry specific coursework).

Experience

• At least 3 years experience in a regulated manufacturing environment with excellent knowledge of quality systems.
• Demonstrated ability to partner with other functional groups to achieve business objectives.
• Strong knowledge of cGMPs (US & EU), OSHA, ISO, and other regulatory agency standards and requirements applicable to material operations in a pharmaceutical production facility.
• Strong communication and interpersonal skills – oral, written and formal presentation skills.
• Creative problem solving skills.

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