Senior Specialist, Quality Assurance Auditor
3 semanas atrás
Job Description
The Role
The Senior Specialist, Quality Assurance Auditor, is responsible for ensuring quality and compliance with both local and international regulatory standards through conducting internal and external audits. In this position, you will offer guidance to internal stakeholders, aiding in defining the company's compliance approach and addressing and mitigating compliance risks.
Key Responsibilities:
- Assess Organon systems, processes, Affiliates, Vendors, Business Partners, and Investigator sites for compliance with regulatory requirements.
- Plan and carry out GVP/GCP audits following the global audit plan, ensuring adherence to local and international guidelines and regulations.
- Generate audit reports and oversee follow-up actions with minimal supervision.
- Conduct meetings with Senior Management to review audit findings and responses.
- Assist in implementing and sustaining the GVP/GCP risk-based strategy, including crafting the annual audit plan.
- Ensure the audit tracking tools are kept up-to-date.
- Participate in regulatory inspections and external audits when necessary.
- Review and provide insights on the quality sections of the Pharmacovigilance System Master File (PSMF).
- Maintain a thorough understanding of global industry expectations and GVP/GCP regulations.
- Train and guide junior team members.
Required Qualifications:
- Bachelor’s degree in a relevant field (Pharmacy, Life Sciences, etc.).
- Minimum of five (5) years of experience in the pharmaceutical sector.
- At least one (1) year of experience in GVP/GCP auditing with EU/FDA/global regulatory requirements.
- Solid knowledge of EMA, FDA, and ICH guidelines.
- Detail-oriented with the ability to work autonomously.
- Proficient in Microsoft applications (Word, Excel, PowerPoint, Outlook).
Preferred Qualifications:
- Proficiency in written and spoken English, additional language skills are a plus.
Primary Skills:
Collaboration and Partnering: Ability to work collaboratively with internal and external partners to achieve quality objectives; possesses strong leadership qualities.
Communication Skills: Excellent verbal and written communication abilities.
Project Management: Skillful in organizing work, prioritizing tasks, and utilizing resources efficiently to meet deadlines and regulatory requirements.
Decision Making: Proficient in utilizing knowledge and data to make timely decisions and assess when issue escalation is necessary.
Business Operations/Field Knowledge: Knowledgeable about regulations, regulatory trends, and business operations, utilizing this knowledge to optimize daily activities and ensure R&D functional areas comply with regulations and procedures.
Who We Are:
Organon is dedicated to providing innovative health solutions that empower individuals to lead fulfilling lives. We are a leading global healthcare company with a focus on improving women's lives, their families, and the communities they serve. With a strong and expanding portfolio, we are committed to addressing the unmet needs in Women's Health, broadening access to top-notch biosimilars, and impacting lives with a diverse range of trusted health solutions. Our Vision is straightforward: A better and healthier everyday life for every woman.
As an equal opportunity employer, we encourage applications from candidates with diverse backgrounds. Our aim is to establish an inclusive environment for all applicants.
If you need reasonable accommodations during the application process or interviews, please contact us.
On-Site Recruitment Advisory
Organon LLC does not accept assistance from search firms for job opportunities. CVs/resumes sent by search firms to any employee at our company without a valid written agreement will be deemed the property of the company.
Annualized Salary Information
Global:
Canada:
The pay ranges vary depending on the local market.
Employee Status:
RegularRelocation:
No relocationVISA Sponsorship:
NoTravel Requirements:
Travel and credentialing requirements must be met, including vaccination prerequisites.Flexible Work Arrangements:
Remote WorkShift:
1st - DayValid Driving License:
NoHazardous Material(s):
Open Positions:
1Requisition ID: R525814
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