Country Clinical Quality Manager Taiwan & Hong Kong

Job Description

Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.

It is critical that, for all our-sponsored clinical trials, patient safety, high quality data and compliance with company requirements and regulations are delivered and sustained. The CCQM position has a significant impact in achieving those objectives. Under the guidance of the Country Clinical Quality Management Lead (CCQM Lead) Taiwan & Hong Kong, the CCQM oversees assigned CQM activities in the respective country/cluster.

WHAT YOU WILL DO

The role requires the ability to properly implement local/global processes/procedures, to identify opportunities for process improvement and to support continuous improvement initiatives. In addition, the CCQMs support audits, inspections as well as Quality Control and local training activities.

• Regulations & Processes

• Training

• Quality Control (QC) Activities

• Audits & Inspections

• Quality / Compliance / Privacy Issue Escalation

• Clinical Supplies GCP Investigations

• Supplier Qualification

• MRL Compliance & Privacy Steward

• Global / Regional Key Initiatives / Projects upon request of the CCQM Lead Taiwan & Hong Kong

WHAT YOU MUST HAVE

Qualifications:

• Bachelor's Degree or equivalent in relevant health care area.

Experience:

• A minimum of 6-8 years of relevant experience in clinical research including direct field monitoring experience or management/oversight of such individuals, with a demonstrated record of accomplishments.

• Deep knowledge and understanding of Clinical Trial processes, GCP and other clinical research related regulations.

• Solid track record of initiating, planning and delivery of projects and knowledge of project management practices.

• Demonstrated experience in leading cross-functional teams.

• Ideally, experience in Clinical Quality Management including Quality Control Activities, Process Management & Improvement.

• Ideally, experience in managing audits and inspections.

• Ideally, experience in coordinating and delivering training sessions.

Skills:

• Superior oral and written communication and leadership skills in an international environment.

• Excellent project management and organizational skills.

• Excellent teamwork skills, including conflict resolution expertise and discretion.

• Ability to analyze, interpret, and solve complex problems.

• Ability to think strategically, objectively and with creativity and innovation.

• Ability to proficiently interact with all levels of clinical research management and exert influence to achieve results.

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.

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

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