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.
- Technical oversight of New Product Introduction, Technology Transfer, Method Development/Qualification.
- Provide advice and guidance in a consultancy capacity to stakeholders for sitewide microbiological issues.
- Point of contact with above site on microbiology matters.
- Support/lead MPS and continuous improvement initiatives regarding to microbiology.
What are we looking for
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.
Who we are
We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
What we look for
Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us-and start making your impact today.
