MSD Manager Quality Operations API-IPC Lab 

Singapore, Singapore 

270563452

Job Description

In this role, you will be responsible for all or subset of the key responsibilities below:

• Ensure that analytical, microbiological testing of incoming materials, in-process samples, cleaning samples, environmental monitoring samples, utility systems, intermediates and finished drug substances or products is performed according to approved procedures and standard lead time.

• Review and approve the implementation of new and revise Analytical Standards.

• Oversee and lead analytical, microbiological method transfer, validation, verification, new product introduction and equipment qualification.

• Ensure inspection readiness of the area with respect to all self-inspections, internal and external audits. When required, provide responses and timely follow-up on relevant corrective actions and commitments made because of the inspections.

• Manage and plan resource utilization to ensure optimal efficiency to meet operation requirements and financial budgets.

• Responsible for training, performance management, development and coaching of direct reports.

• Manage escalations and senior stakeholders for the respective operations, including financial targets and related efficiency and productivity KPIs for the overall team.

• Drive collaboration and transformational culture change.

• Strategize and lead key Quality initiatives such as implementation of model areas and digitalization.

• Review and approve Quality documentation such as change control, deviations, protocols and summary reports.

• Ensures consistent execution of safety programs to maintain a safe working environment.

Qualifications & Experience

• Bachelor’s degree in Science or Life Science, Pharmaceutical Science, Engineering or proven relevant experience.

• Minimum 7 years of applied professional work experience in the quality operations in pharmaceutical manufacturing.

• Demonstrated experience in change and project management with ability to lead a cross functional high-performance team.

• Experience and expert knowledge of regulatory standards, compliance procedures and quality systems especially for Singapore, EU or US markets.

Personal Qualities

• Demonstrated people management skills and ability to influence and collaborate with stakeholders at senior levels.

• Customer focus with strong business acumen and continuous improvement mindset.

• Strategic and critical thinking mindset with a collaborative and problem-solving attitude.

• Strong communication and interpersonal skills.

• Passionate in coaching and mentoring with a focus on creating an inclusive quality culture.

What we look for

Current Contingent Workers apply

Not Applicable

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