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DEU - Munich, Germany
Onsite
Job Description
The position
The In-Market Quality Compliance Senior Specialist reports to the Quality & Compliance Director Distribution & In-Market Quality (DIMQ).
The incumbent is responsible for ensuring the compliance of Distribution & In-Market Quality (DIMQ) processes against approved quality manual documents and aiding in the assurance of robust business systems in compliance with Company policies. The incumbent functions under the the leadership of the Director of Compliance, but is expected to work independently with minimal direction. A main element of the role is to enhance existing business processes and/or quality systems and help identify and advance performance improvement activities.
Will be part of a small team of DIMQ professionals accountable for ensuring robust and effective Quality and Business systems are in place for the achievement of GDP/GMP/MD compliance (as applicable). Provides guidance to the team, in areas of expertise, so together they ensure Quality performance and quality and business systems.
The incumbent provides technical expertise and direction, to the compliance team and other DIMQ team members ; ensures that appropriate Quality Systems are established, implemented and maintained as relevant to DIMQ, while working within the bounds of the global Quality Management System.
This is a fixed term role for one year.
Responsibilities
Quality Compliance & Quality Systems
Ensure Distribution & In-Market Quality processes remain compliant with applicable GDP, GMP, Medical Device regulations, company standards, and global quality requirements.
Support the deployment and implementation of new or revised Quality Management System (QMS) policies, procedures, and standards.
Help identify, drive, and implement continuous improvement initiatives that enhance quality performance and operational efficiency.
Share learnings and best practices from internal and external quality audits to strengthen compliance across the organization.
Support management reviews and governance forums, including Quality Council and QMS Council activities.
Quality Operations
Support the documentation, investigation, tracking, and reporting of Product Quality Complaints, including coordination of PQC sample management.
Contribute to customer qualification activities, product risk assessments, Annual Product Quality Reviews, and temperature excursion investigations as required.
Participate in projects and business initiatives, providing quality guidance to ensure compliance, business continuity, and operational excellence.
Monitor regulatory developments and industry trends, particularly those impacting pharmaceutical importation, distribution, and in-market quality activities.
Cross-Functional Collaboration
Partner closely with Global Quality, External Manufacturing Quality, Supply Chain, Regulatory Affairs, Pharmacovigilance, Medical Affairs, and Quality Units across the manufacturing network.
Build strong relationships with key stakeholders to ensure alignment on quality priorities and compliance expectations.
Serve as a trusted advisor on quality and compliance matters within your area of expertise.
Training & Capability Building
Complete and maintain all required training related to the role.
Support the effectiveness of training programs through assessment, documentation, and continuous improvement.
Provide guidance and expertise to colleagues within the DIMQ team on quality compliance and quality systems topics.
Required Education, Experience, and Skills
Bachelor or Masters Degree in Chemistry, Pharmacy, Biology, Microbiology, Chemical Engineering (or equivalent)
Solid knowledge of global cGDPs/GMPs and Medical Device Regulations relevant to Marketing Authorization Holders
Strong compliance mindset, excellent project management and organizations skills
Good problem solving skills, based on science, facts, data and understanding of regulatory requirements in complex and evolving environments; must be able to apply sound risk management principles
Ability to work collaboratively in team settings, across functions, and within matrix organizations to achieve objectives
Strong demonstrated interpersonal, communication, collaborative and leadership skills in dealing with a broad variety of issues
Demonstrated ability to create simplicity out of complex environments and challenges
Minimum of 5 year's experience in the pharmaceutical industry, with solid compliance experience.
Must have expertise and broad experience in Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GDP and regulatory requirements.
Secondary Job Description
Who We Are:
Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman.
As an equal opportunity employer, we welcome applications from candidates with a diverse background. We are committed to creating an inclusive environment for all our applicants.
Search Firm Representatives Please Read Carefully
Organon LLC, 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.
Annualized Salary Range
Annualized Salary Range (Global)
Annualized Salary Range (Canada)
Please Note: Pay ranges are specific to local market and therefore vary from country to country.
Employee Status:
Project Temps (Fixed Term)Relocation:
No relocationVISA Sponsorship:
Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites
Flexible Work Arrangements:
Shift:
Valid Driving License:
Hazardous Material(s):
Number of Openings:
1