Global Audit Program Director

Vor 2 Tagen

Basel, Schweiz Moderna Therapeutics Vollzeit

**The Role**:
Reporting to the Sr Director, Global Quality Compliance, the Director of the Global Audit Program will be responsible for global quality audit program. The individual will be responsible for developing, approving, monitoring, and maintaining the global audit schedule for all Moderna manufactures, entities, service providers and suppliers. Additionally, the individual we ensure a robust audit process is established that is risk based and predicative in identifying compliance risk.

The individual will ensure comprehensive practices are implemented across Moderna’s global quality compliance program that will certify audit outcomes, responses and associated CAPA’s. In collaboration with the key stakeholders, the team will implement and a establish a life cycle of continuous improvement. The individual will also maintain a certified auditor program.

**Here’s What You’ll Do**:
**Manage all aspects of the audit lifecycle**: scheduling, planning, issuing agendas, executing, issuing reports, evaluating responses, requesting clarification, issuing CAPA, and closing

Incorporate sound risk management principles for the establishment of the annual audit schedule.

Develop and maintain updates to annual global audit schedule

Perform internal audits for Moderna affiliates and sites

Work directly with auditees to ensure completion of correct CAPA to address compliance concerns identified during audits

Identify compliance risks and escalate issues to appropriate levels of management for resolution

Develop and report trends based on internal / external regulatory observations to better focus the scope of audits

Manage auditors that support the audit program and ensure that they have the required skills, training and procedural qualification requirements

Drive consistency with audit report observation classification, status and overall risk

Participate in the development, implementation and maintenance of procedures and templates to assist the evaluation and audit process

Assist with the development and manage the auditor qualification, training requirements and develop effective auditing tools

Create, publish, and maintain metrics that measure the health and effectiveness of the audit program

Identify and drive program improvements.

**Here’s What You’ll Bring to the Table**:
Bachelor degree, preferably in Sciences or Engineering with applied Quality industry experience. BS with 8-10 years of experience or MS with 5-8 years experience in a pharmaceutical or biotechnology company.

Exceptional knowledge in product regulatory requirements

In-depth working knowledge of US and worldwide GxP regulations

Ability to build positive relationships to foster a collaborative approach to proactive compliance activities

Ability to prioritize multiple priorities, projects, and team members, as well as adapt to changing business needs

Excellent communication skills; including technical writing and presentation skills

Demonstrated teamwork and mediation skills; ability to work through conflicting situations

Ability to broker a strategic position after taking feedback from multiple sources

Experience driving decision making

Ability to succinctly communicate level of risk, priority, or impact to the business

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 winter break
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 is a smoke-free, alcohol-free and drug-free wor

  • Associate Director Global Program Mgnt

    Vor 2 Tagen

    Basel, Schweiz Novartis Vollzeit

    391607BR **Associate Director Global Program Mgnt**: Switzerland **About the role** The key accountabilities for the Associate Director, Global Program Management, Oncology are as follows: - Lead project teams with respect to the timing, scenario/options development, risk management, opportunities / challenges, and requirements of interfacing with...

  • Assoc. Director

    Vor 5 Tagen

    Basel, Schweiz Novartis Vollzeit

    393012BR **Assoc. Director - Global Program Management Immunology (80-100%*)**: Switzerland **About the role** Location: Basel, Switzerland Fulltime, Hybrid, #LI-Hybrid Improving and extending people's lives is what we do. It’s our purpose, our calling - the summit we’re always striving to reach. Key to this mission is our Project Management teams in...

  • Completions Program Director

    Vor 3 Tagen

    Basel, Schweiz Jet Aviation Vollzeit

    As the Completion Program Director of Jet Aviation you will be responsible for VIP Aircraft completions programs with a revenue greater than 25M USD. You will coach a core team of up to 10 members across the program life cycle. You must take a quantitative approach to risk management, monitoring financial performance & reporting to executive leadership. As...

  • Global Director Patient Support Program

    Vor 3 Tagen

    Basel, Schweiz Novartis Vollzeit

    766 million. That’s how many lives our products touched in 2021 and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives. Global Director, Patient Support Program is a strategic position to drive the best-in class One Patient Support Program (PSP) to Novartis patients. The incumbent identifies...

  • Defence Program Director

    Vor 4 Tagen

    Basel, Schweiz Jet Aviation AG Vollzeit

    This position is responsible for Defence program. You will coach a core team of up to 10 members across the program life cycle. You will also have to take a quantitative approach to risk management, monitoring financial performance & reporting to executive leadership. As Jet Aviation’s Defence Program Director your actions have to be in line with the...

  • Director, Global Environmental Program/services

    Vor 4 Tagen

    Basel, Schweiz Lonza Vollzeit

    Switzerland, BaselToday, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big...

  • Director Program Management Airbus

    Vor 7 Tagen

    Basel, Schweiz Hawker Pacific Vollzeit

    Summary: Since 1967, Jet Aviation has been crafting flight in its smoothest form. From one hangar in Basel, Switzerland, to some 4,000 employees, and some 50 locations worldwide. Aircraft Management, Aircraft Sales, Charter, Completions, Defence, FBO, Fixed and Rotary Wing Maintenance, and Staffing. Behind every seamless Jet Aviation experience, is a team of...

  • Head of Global Quality Compliance and Audit

    vor 2 Wochen

    Basel, Schweiz Lonza Vollzeit

    Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small,...

  • Director Program Management Airbus

    Vor 7 Tagen

    Basel, Schweiz Jet Aviation AG Vollzeit

    The Director Program Management Large Aircraft is fully accountable for the successful performance of Large Aircraft projects. The Director Program Management Large Aircraft provides leadership and direction for all aspects of the programs. In addition, the job incumbent will be responsible for the related workshops working under P145 regulations at Basel...

  • Global Program Head

    Vor 5 Tagen

    Basel, Schweiz Novartis Vollzeit

    10! That’s how many pipeline projects Immunology, Hepatology, Dermatology (IHD) has in Phase 3 or registration and over 25 projects in Phase 1/2. Our IHD Unit has a pipeline with depth and breadth and is known to be a talent powerhouse. We are uniquely positioned to have a critical impact on bringing innovative medicines to patients across multiple...

  • Executive Director, Global Health

    vor 2 Stunden

    Basel, Schweiz Novartis Vollzeit

    393300BR **Executive Director, Global Health & Sustainability Communications**: Switzerland **About the role** Location: Basel, Switzerland As the Executive Director, Global Health & Sustainability Communications, you will drive integrated communication support to the Novartis Global Health function including access to medicine, Environmental, Social and...

  • Director of Transformation Programs

    Vor 5 Tagen

    Basel, Schweiz Groupeonepoint Vollzeit

    Director of Transformation Programs - Financial ServicesApply remote type Hybride locations New York City time type Full time posted on Posted 3 Days Ago job requisition id JR102105About OnepointAt Onepoint, we are more than consultants - we are transformation architects. Our mission is to guide organizations through strategic transformation, technological...

  • Associate Director Global Scientific Affairs

    Vor 5 Tagen

    Basel, Schweiz Sobi Vollzeit

    **Sobi offers the opportunity to work at an international pharmaceutical company focused on specialty pharmaceuticals meeting the high medical needs of rare disease patients and providing treatment and services to them. Our employees come from a variety of backgrounds within research, healthcare, industry and the academic sphere.** **Associate Director...

  • Clinical Project Director

    Vor 5 Tagen

    Basel, Schweiz Global Personal Partner Vollzeit

    **EINFÜHRUNG**: Our profession and our passion "HR Management." Global Personal is an independent company of the Interiman Group SA with over 100 employees offering a complete range of human resources services at 21 locations in German-speaking Switzerland. For our client, an international orientated Pharma company in Basel we are looking for a reliable...

  • Manager - Audit Global Accounts

    Vor 5 Tagen

    Basel, Schweiz KPMG Vollzeit

    You want to become part of an international, innovative and successful team in a highly engaging culture that performs audits on medium and large-sized industrial enterprises? Our Basel audit group is actively looking for highly motivated individuals to join their team. Be part of our growing international audit business in Basel! Basel Upon Agreement 100...

  • Global Program Clinical Head

    Vor 4 Tagen

    Basel, Schweiz Novartis Vollzeit

    393119BR **Global Program Clinical Head - Neurosciences**: Switzerland **About the role** With more than 60-year history in neuroscience, Novartis brought landmark therapies to patients with Multiple Sclerosis, Alzheimer’s disease, Parkinson’s Disease, Epilepsy, Depression and Migraine. We have an extraordinary pipeline in neuro-inflammation,...

  • Senior Global Marketing Director Nephrology

    Vor 5 Tagen

    Basel, Schweiz Sobi - Swedish Orphan Biovitrum AB (publ) Vollzeit

    Senior Global Marketing Director NephrologyCompany DescriptionAt Sobi, each person brings their unique talents to work as a team and make a difference. We are dedicated to developing and delivering innovative therapies to improve the lives of rare disease patients, and our edge comes from our team of people. There are some good reasons to join our team:...

  • Assistant Manager

    Vor 6 Tagen

    Basel, Schweiz KPMG Vollzeit

    You want to become part of an international, innovative and successful team in a highly engaging culture that performs audits on medium and large-sized industrial enterprises? Our Basel audit group is actively looking for highly motivated individuals to join their team. Be part of our growing international audit business in Basel! Bewirb dich...

  • Sustainability Reporting Manager

    Vor 5 Tagen

    Basel, Schweiz Audit International Vollzeit

    Job type: Perm Town/City: Basel Country: Switzerland Salary/Rate: 0 Specialism: Internal Audit Seniority: Manager Job ref: JMK79 Post Date: 07.11.24 About the Role Responsibilities Manage non-financial annual reporting: Set reporting standards and requirements, lead cross-functional reporting team, ensure data integrity and...

  • Associate Director, Global Logistics

    Vor 4 Tagen

    Basel, Schweiz Moderna Vollzeit

    **The Role**: The Associate Director of Global Logistics Project Resilience is a newly created position responsible to lead the Global Logistics Workstream in Moderna’s Resilience project to establish 3 manufacturing sites in Australia, Canada and UK. He/She must ensure that the logistics set-up is an accurate reflection of the business requirements and in...