Job Description

The Role:
As Moderna continues its international growth, we are seeking an experienced Quality Assurance professional to lead our QA activities in South East Asia.

As Director, Country Head, Quality Assurance, you will be responsible to ensure the organization (and monitoring) of the company\'s vaccine/pharmaceutical operations are conducted in agreement with company standards and applicable regulations. These operations range from manufacturing, distribution, advertising, information, product quality, batch monitoring and recall, to the corresponding storage operations, where appropriate.

Working in collaboration with Global and Local Quality Heads, you must ensure that all vaccine/pharmaceutical related activities are conducted in the respect of applicable:

Good Practices (GxP);

Procedures (Policies, SOPs);

Marketing authorization;

Contracts and quality technical agreements.

We are seeking for this person to be bold in suggesting new and innovative process and systems improvements \xe2\x80\x93 working in a highly collaborative way (that maintains a flat organization and supports fast decision-making) you will be relentless in your pursuit of excellence.

If you are forward-thinking, dynamic in your outlook, and attracted to a challenge which is demanding and rewarding \xe2\x80\x93 this is your next step.

Here\xe2\x80\x99s What You\xe2\x80\x99ll Do:
Serve as Company\'s Management Representative

Ensure Local Implementation, application, and maintenance of the company\'s quality system

Lead preparation of Quality Reviews

Lead monitoring and management review of Quality KPIs

Develop and administer department budgets, schedules, and other administrative functions.

Ensure Creation, update and application of procedural documents (SOPs)

Lead preparation of internal and external audits, inspections, certifications and monitoring of associated CAPAs for manufacturing (GMP)

Support, as requested for GCP, GVP inspections

Reporting to the Local Pharmaceuticals Agency any placing on the national market of a medicine which he considers to be falsified, for which he ensures the distribution.

Lead local Risk analysis

Ensure appropriate Complaint management

Ensure appropriate Deviation management

Management of vaccine/pharmaceutical subcontractors for local market: ensuring that the transportation conditions guarantee the appropriate conservation, integrity and security of the products.

Ensure implementation and monitoring of the distribution system (contracts, specifications, etc.)

Ensure stock monitoring from a quality perspective (stock forecast, authorization to distribute, declaration in the event of a risk or confirmed shortage, transport conditions, batch recall, returns, etc.)

This list is non exhaustive. Other missions may be added.

Here\xe2\x80\x99s What You\xe2\x80\x99ll Bring to the Table:
Bachelor\xe2\x80\x99s degree in relevant scientific discipline

Additional qualifications (MSc, PhD, MBA, Qualified Person) are advantageous

+10 years Significative experience within the pharmaceutical industry (quality, regulatory and pharmacovigilance area)

Working knowledge of relevant local and international regulations and ICH, ISPE, ASTM standards/guidelines

Strong understanding of pharmaceutical business and quality governance

Ability to work across multiple business functions to build consensus

Experience leading team/budget (functional or project acquired experience)

Experience in hosting and collaborating with national or international regulatory agencies

Excellent interpersonal skills

Outstanding communication skills (verbal and written)

Experience working with CMOs, CLOs, vendors preferred

Ability to conceptualize, analyze, plan and manage in a fast-paced environment.

Ability to be agile and effectively collaborate in a dynamic, cross-functional matrix environment.

Ability to navigate through ambiguity and rapid growth and adapt to change.

Language skills:
Fluency in English (written and spoken) is essential

Fluency / Knowledge of additional languages is advantageous but not essential

Moderna offers personalized benefit programs and well-being resources as unique as our global workforce so employees can do their best work.

We recognize and appreciate your diverse needs and interests and do our best to support you at work and at home with:
Quality healthcare and insurance benefits
Lifestyle Spending Accounts to create your own pathway to well-being
Free premium access to fitness, nutrition, and mindfulness classes
Family planning and adoption benefits
Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, and a discretionary year-end shutdown
Educational resources
Savings and investments
Location-specific perks and extras!

The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work.

About Moderna
In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna\'s capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.

Moderna\'s mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit www.modernatx.com.

Moderna is a smoke-free, alcohol-free and drug-free work environment.
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