Sr GMP GDP Auditor

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At Sobi, the work we do every day redefines the standards of care and transform the lives of people living with rare diseases.

As a diverse team of entrepreneurial people, we are passionate about our growth journey towards becoming a global leader, making a difference for rare disease patients, moving quickly and always challenging the status quo.

We are committed to an inclusive, sustainable and flexible workplace that fosters growth and development.

The purpose of the position is to perform GMP GDP Audits (GMP, GDP,) and contribute to develop and maintain the global Sobi GMP GDP audit strategy and audit program(s). The audits will be both internal audits/self-inspections within Sobi’s QMS as well as external audits of Sobi’s CMOs, suppliers and service providers. The employee will also have the main responsibility for the administration of audits and audit programs and plannings in the computerised systems at Sobi.

Key Responsibilities

- Drive strategic development of an effective global risk-based audit strategy (internal & external) and

program. Collect, collate, and incorporate input into the audit strategy and plan.

- Plan, lead, conduct, document, and follow-up of internal and external GMP GDP audits (Primarily

dedicated to GMP/GDP) as Lead Auditor or Co Auditor of Sobi’s CMOs, suppliers and service providers)

according to the requirements specified in the respective Sobi procedures (as well as applicable

regulations, standards, quality agreements, and guidance documents) working ins strong collaboration

with the GMP GDP Audit coordinator and relevant stakeholders.

- Lead Auditor or Co Auditor of internal audits/self-inspections within Sobi’s QMS as well as

- Provide regulatory guidance for timely remediation and recommendations regarding acceptability of the

proposed filing

- Ensure appropriate escalation to responsible management in case of critical findings and support

immediate follow-up. Ensure adequate definition and recording of mitigation plans when applicable.

- Assess the adequacy of responses (CAPA plans) to audit findings in cooperation with the GMP GDP Audit

coordinator and other stakeholder QA representative and Auditee.

- Prepare regular status report on performed GMP GDP audits (Primarily dedicated to GMP/GDP), audit

trending and agreed upon metrics to ensure oversight.

- Support Authority inspections and partner audits

- Maintain knowledge of company policies, SOPs, and supporting documents related to drug

development/manufacturing/distribution as well as FDA and EU regulations and ICH guidance documents

(as applicable) along with any other national or international regulations

- SOP Author for SOPs related to GMP GDP audits including supporting documents Act as GMP GDP

compliance consultant for GMP GDP trainings, task forces, continuous improvement projects as needed.

- Act as GMP GDP compliance consultant for GMP GDP trainings, task forces, continuous improvement projects as needed.

Education/Learning Experience/Work Experience

· University degree in Life Sciences or related discipline.

· At least 10 years’ experience from the pharmaceutical industry with GMP/GDP responsibilities.

· Experience of Lead GMP GDP audits/inspections.

· Experience working as GMP GDP Inspector, or Auditor in the field of Biotechnology and Sterile

Manufacturing

Skills/Knowledge/Languages

· Excellent knowhow of the EU/US/RoW regulations within GMP GDP

· Excellent verbal and written communication skills

· Excellent knowledge in document handling in computerised systems

Personal Attributes

· Delivery focus

· Collaborative

· Structured and detail oriented

· Strong individual initiative, organizational/people skills and multi-tasking abilities

· Ownership, paternership and sense of urgency

Additional Comments

The position require ability and willingness to travel in connection with performing on-site audits.

 

Compensation: 
The base salary pay range for this role is $120,000-$180,000 annually. Actual pay for this position will take into account factors such as experience and location. In addition to a base salary, this position is also eligible for a competitive 401k match, short and long-term incentives, medical, dental, vision, STD/LTD and life insurance benefits, in addition to other health and wellness programs and offerings. 

Career Growth Opportunities: 
At Sobi, we are committed to your professional growth. As the Director of Strategic Accounts, you will have opportunities for career advancement and leadership development within our organization should they align with your professional objectives. 

Innovation and Impact: 
Join us in our mission to develop groundbreaking therapies that transform the lives of patients with rare diseases. Your work will directly contribute to innovative treatments that make a real difference. 

Testimonials: 
Hear from our team: “I am so proud to be with Sobi for nearly 14 years and while the company has grown, evolved and become more innovative over the years, what has not changed is our collaborative environment, patient-first culture, and tireless passion for making a difference in people’s lives. It’s truly inspiring to work alongside people who care so deeply about the work we do.” -Dean Pioch, National Commercial Business Director, Kineret  

Call to Action: 
Ready to make a difference? Apply now to join our team and be part of a company that is transforming the lives of patients with rare diseases. 

Why Join Us?

We are a global company with over 1,700 employees in more than 30 countries and are committed to the societies where we operate. With a deeply skilled management team directing our day-to-day wins, and a Board with a stellar track record, we’re ready to take on the world’s diseases, ailments and adversity. Our people believe they have the power to make a positive impact in others’ lives because that’s exactly what we do here. If you’re seeking a career that taps into your talents in a way that makes the world a better, healthier place, we just may have a job for you.

We know our employees are our most valuable asset, and our culture conveys that. We offer a competitive benefits package, to support the health and happiness of our staff.

Sobi Culture

At Sobi, we refuse to accept the status quo. This is because we have witnessed first-hand the challenges facing those affected by rare diseases, and have used this knowledge to shape our business to find new ways of helping them.

As a specialized biopharmaceutical company, we are dedicated to rare diseases. And we see this focus as a strength. By effectively turning our research into ground-breaking treatments, we help make medicine more accessible and open up more possibilities for patients and more opportunities for those caring for them. This has been our approach since day one, but we know we can’t change the world of rare diseases on our own. Accomplishing this requires strong partnerships with patients, partners and stakeholders across the entire value chain. Together, we define how our business can create solutions that serve the needs of those affected by rare diseases while facilitating sustainable growth.

An Equal Opportunity Employer

Sobi is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at Sobi are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity, protected veterans and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status or protected groups by the laws or regulations in the locations where we operate.

Sobi is an affirmative action and equal opportunity employer. Disabled/Veterans. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation if you are unable or limited in your ability to use or access this website to apply for a vacancy as a result of your disability. You can request reasonable accommodations by sending an email to [email protected]

COVID-19 Policy

For the safety of our employees and all individuals with whom we interact professionally, Sobi North America requires all new hires in the U.S. to be fully vaccinated for COVID-19 with proof of vaccination status. We will consider requests for reasonable medical or religious accommodations, as well as any state-specific exemptions, as required by applicable law.