MSD Associate Director Microbiology 

Singapore, Singapore 

833125056

Job Description

Associate Director, Quality Control, Site Microbiology SME

The position of Associate Director in Quality Operation will play a key role in supporting sitewide on the microbiology expertise, not limited to, Quality Microbiology Laboratory, Manufacturing and Utilities. The role will ensure and maintain high standards of quality and compliance within our organization.

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

• 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.

• Strategize and lead key Microbiology initiatives such as implementation of contamination reduction, sample optimization, etc.

• Manage escalations and senior stakeholders for the microbiology matters, including financial targets and related efficiency and productivity KPIs.

• Drive collaboration and transformational culture change.

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

• Technical support for microbiology deviations, including escalation and above site contact and review.

• Provide guidance, review, and approve as business owner for Quality topics relating to microbiology, environmental monitoring risk-based design Quality Risk Analyses and Contamination control strategy & plan.

• Technical reviewer for new qualifications, new methodologies, or facilities with major changes.

• Technicaloversight of New Product Introduction, Technology Transfer, Method Development/Qualification.

• Provideadvice and guidance in a consultancy capacity to stakeholders for sitewide microbiological issues.

• Pointof contact with above site on microbiology matters.

• Support/lead MPS and continuous improvement initiatives regarding to microbiology.

Qualifications & Experience

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

• Minimum 10 years of applied professional work experience in microbiology in pharmaceutical or sterile manufacturing.

• Demonstrated experience in change and project management with ability to communicate across sites.

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

Personal Qualities

• Demonstrated ability to influence/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 culture.

What we look for

Current Contingent Workers apply

Not Applicable

*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.