Manager Quality Operations Services

Job Description

Manager Quality Operations Services

Purpose of the role

Ensure that the quality systems and processes are in place, up to date and comply with latest guidelines for all Organon BT systems that are used on site, like Athena, ORGLIMS, ETQ, GLAMS, Archive system

In this way provide service to the Oss site in operational setting the systems up for use as well as support further digitalization in alignment with the Quality digital roadmap Execute in compliance with cGMP and applicable Organon QMS requirements. Create and support ‘’safety first, quality always’’ mindset throughout the whole organization

Welcome to the team

The team consists of approximately 10-15 positions. Responsibilities are divided among the process steward for Athena and OrgLims, specialist QOS, associate specialist QOS, senior technician QOS and technician QOS

Main responsibilities

• Establish and approve compliant Quality data within site systems, including Document Management Systems and the site archive.
• Ensure Quality-compliant approval of product artwork, material master data, registration information/notifications, and Quality master data within laboratory-related systems (e.g. SAP, ORGLIMS). Plan activities and monitor performance accordingly.
• Ensure site sustainment of SAP Quality Management (QM) and ORGLIMS. Act as Site SAP QM Steward, while the ORGLIMS Steward (Improvement Engineer) leads the implementation of SAP and ORGLIMS enhancements at the Oss site.
• Provide collection and archiving services for Quality Operations.
• Organize and oversee (annual) GMP training programs at site level.
• Ensure all team activities are executed in full compliance with the Quality System.
• Develop and submit budget proposals for personnel, investments, and project activities as required.
• Provide data-driven input to ensure adequate qualitative and quantitative staffing for team operations and the department project portfolio and contribute to the development of the CoE profit plan.
• Provide input to, and lead the execution of, Quality process digitalization initiatives, including the development of a site roadmap aimed at improving productivity and efficiency.
• Initiate and contribute to the development of improvement business cases and lead the implementation of improvement initiatives focused on efficiency and/or effectiveness.
• Take responsibility for benchmarking activities, with a strong focus on continuous improvement using IPS methodologies.
• Monitor, initiate, and ensure the accurate administration and implementation of data (e.g. performance indicators) and documentation (e.g. SOPs) in accordance with established procedures and guidelines.
• Maintain a thorough understanding of both historical and status of Quality data and documentation.
• In cooperation with CoE-HR and in line with HR policies and procedures, contribute to recruitment and retention activities, the development and execution of training programs, and the execution of performance management processes.
• Ensure the availability of the appropriate number of qualified staff and support the development and empowerment of employees, enabling the team to deliver the required output.
• Ensure implementation of corporate Safety, Health, and Environment (SHE) policies by creating working conditions that enable compliance with all relevant legislation and company requirements. Demonstrate visible personal commitment to safe, healthy, and environmentally responsible working practices, and actively promote continuous improvement in SHE performance.
• Act as the Site ETQ Lead and represent the site within Organon Communities of Practice for relevant topics.
• Provide support during inspections, customer audits, and notified body audits (front and back office), including preparation and provision of documentation for desk-based audits.

Your profile

• Master’s degree.
• Minimum of 10 years of relevant experience, including people management, preferably within the pharmaceutical industry.
• Thorough understanding of quality regulations and the interaction of Quality Systems used in manufacturing and/or analytical processes.
• Demonstrated ability to leverage Quality as a competitive advantage and to embed a strong quality mindset across the Oss site.
• Strong coaching, empowering, and people management skills.
• Excellent analytical and structural thinking capabilities.
• Effective communication and influencing skills.
• Stakeholder-focused, with the ability to understand stakeholder needs and to build, develop, and maintain strong relationships.
• Proven lean leadership with a strong drive for continuous improvement and simplification.
• Basic understanding of project management principles.
• Strong oral and written communication skills in both Dutch and English.

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:

Regular

Relocation:

No 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:

1