Quality Compliance Management

Reference No. R2782172 

The B100 Maintenance Compliance Manager will lead deviation investigations; ensure B100 Maintenance compliance and the execution of continuous improvement initiatives as a result of deviation investigations within the B100 Maintenance department.

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Responsible for all significant and non-significant deviations associated with B100 Maintenance Department (60%).

• Determine the scope of the investigation by collaborating with Quality Operations (QO), Manufacturing and Subject Matter Experts (SME) as appropriate in real time on the shop floor.

• Lead and develop an investigation strategy in collaboration with Manufacturing, Quality Operations, and SMEs.

• Perform Root Cause Analysis by conducting Shop Floor Production Walkthrough (GEMBA), select appropriate analytical tools, collect and analyze data to determine the true root cause.

• Identify expertise required for the investigation (MTech, Technical Services, QC, QOVS, QOSA, etc.).

• Identify, co-ordinate and manage contributions from other departments.

• Participate in Autonomous Production Team (APT) support team meetings for planning and execution of investigations.

• Review and provide guidance on reports prepared by technical staff.

• Prepare manufacturing investigations to support other functional areas as requested.

• Write and manage associated documentation, actions, and timelines

• Responsible to ensure that investigation reports and/or manufacturing investigation reports are clear, concise, and comprehensive.

• Manage the deviation review process and ensure deviation investigations are closed according to targeted timelines.

• Ensure actions are assigned to the appropriate individuals and completed to meet timelines.

Develop and execute appropriate corrective and preventive actions (CAPA). (10%)

• In collaboration with platform management and other stakeholders, develop appropriate CAPAs with a clearly defined scope to address the root cause.

• Initiate CAPAs in the Quality System as required.

• Update GMP documents arising from CAPAs.

• Manage CAPAs assigned to B100 Maintenance Department to ensure completion by the targeted timelines.

• Review CAPAs associated with recurring issues and escalate any issues to Platform Leaders.

• Work with Platform Leaders to identify and develop process improvements to remediate risks.

Develop Investigation cases to present at Governance boards. (10%)

• Work with SMEs and appropriate QO experts; develop assessment of risk to product, process, and other stages.

• Utilize the Deviation Review Board Governance as required.

• Prepare for Regulatory inspections by drafting investigation briefing packages / hot topics as applicable.

• Provide support to the area manager during Regulatory inspections and other audits.

Responsible for Shop Floor Compliance within the Platform (10%)

• Prepare documents required for Maintenance planned and unplanned events and area restoration for Quality release of classified environments.

• Create and manage change request to implement changes within GMP scope to ensure timely closure.

• Track and develop action plan to address gaps, as required.

Continuous Improvement and GMP Documentation Review within the Platform (10%)

• Lead continuous improvement initiatives as outputs of investigations and provide compliance direction and monitoring as related to Shop Floor operations.

• Participate in special projects for process improvement projects to meet GMP requirements and address inspection observations.

• Provides metrics and other reports as required.

• Support GMP Documentation review as required.

• Breadth of responsibility (global/regional/country/site): Reporting to the Deputy Director, B100 APU Maintenance Lead, the B100 Maintenance Compliance Manager will be a member of the B100 Maintenance Team.

Key dimensions:

• The B100 Maintenance Compliance Manager would have no direct reports but would interface and coordinate with all other members of the B100 Maintenance team and other cross-functioning departments.

Freedom to act, level of autonomy:

Specific degree, duration of experience (Required to hold the job):      

• Minimum university degree in Microbiology, Biochemistry, Engineering, Biotechnology or Related Science or higher-level Education.

• Minimum of (4) years relevant experience in Commercial Manufacturing, Manufacturing Technology, Quality Operations or similar role. 

Key technical competencies and soft skills:

• High level of knowledge of cGMPs in pharmaceuticals/biological manufacturing environment

• Experience in regulatory inspections

• Good problem-solving skills

• Excellent communication and organization skills.

• Excellent technical writing skills

• Six-sigma or other root cause training and experience

• Knowledge and experience with multiple software programs such as SAP, Trackwise, Word, Outlook, Visio and PowerPoint

Why Choose Us?

• Bring the miracles of science to life alongside a supportive, future-focused team.

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs