Systems Quality and Compliance Senior Specialist

Job Description

Organon is looking to hire a Senior Specialist, Systems Quality and Compliance, that will play a critical role in ensuring that all GxP computerized systems comply with internal quality standards and global regulatory requirements. This position provides quality oversight throughout the Software Development Lifecycle (SDLC) and supports the implementation and maintenance of validated systems across the organization.

The role involves close collaboration with Business Process Owners, Data Owners, IT, and external vendors to ensure systems remain in a validated and controlled state. The incumbent will contribute to the development, review, and approval of validation documentation, SOPs, training materials, and quality-related communications.

Responsibilities:

• Provide quality oversight for GxP computerized systems throughout the SDLC.

• Ensure compliance with applicable regulatory requirements, internal policies, and procedures.

• Support validation activities, including planning, execution, and documentation.

• Develop and maintain validation documentation, SOPs, training materials, and quality alerts.

• Collaborate with cross-functional teams to identify and implement quality improvement strategies.

• Review audit and inspection findings and support remediation efforts.

• Engage with internal and external stakeholders to ensure alignment on quality expectations.

• Manage relationships with third-party vendors and development partners.

• Support IT project delivery with a focus on quality governance and compliance.

• Participate in global projects and work effectively in multicultural environments.

Required Skills & Experience:

• Bachelor's degree in Science, Pharmacy, Computer Science, or Business Administration.

• Minimum of 5 years of experience in Quality Assurance or Compliance in the pharmaceutical or biotech industry.

• Strong understanding of computerized system validation principles and global regulatory requirements.

• Experience with validated solution delivery, regulated application support, or vendor oversight.

• Familiarity with quality systems implementation in pharmaceutical, laboratory, or manufacturing environments.

• Excellent communication, facilitation, and stakeholder engagement skills.

• Ability to work independently and manage multiple priorities in a dynamic environment.

Preferred Qualifications:

• Knowledge of GAMP and ICH validation guidance.

• Experience with SaaS/PaaS ecosystems and data migration.

• Experience in manufacturing, laboratory, supply chain, or shop-floor environments.

• Prior experience working across countries and cultures.

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:

Relocation:

VISA 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: