Quality Responsible Person, Senior Specialist Quality Assurance

at  Organon

Job Description

PREFERRED EDUCATION, EXPERIENCE, AND SKILLS

• Previous experience of holding a position as Quality Responsible Person is preferred

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.
If you require reasonable accommodation(s) in completing an application, interviewing, or otherwise participating in the employee selection process, please email us at staffingaadar@organon.com.

Required Education, Experience, and Skills

• Master of Science in Pharmacy or other life science Master’s degree (such as biology, medicine, chemistry)
• At least 2 years’ experience from a quality assurance position in the pharmaceutical industry.
• Strong leadership skills and problem-solving skills
• Excellent communication and prioritization skills
• Fluency in Danish and Englis

• Being the primary point of contact for local Health Authorities with regards to quality matters
• Ensuring fulfillment with applicable local regulations such as GDP Executive order no. 1541 2019 on distribution of medicinal products and the EU Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use.
• Responsibility, creation and maintenance of Quality Management System procedures pertaining to the Quality (GDP) area
• Ensuring handling of Product Quality Complaints (PQCs)
• Ensuring handling of, and being overall responsible for, local quality tasks and responsibilities related to e.g. deviations, CAPAs, recalls, self-inspections and audits, change control, quality risk management, returns, destructions, customer and supplier qualification, counterfeit management and serialization
• Ensuring training of personnel and maintenance of local quality training programs
• Ensuring internal reporting and agency notifications of stock-outs
• Local management of administrative holds
• Management of product samples and repackaging/re-stickering activities as needed
• Reviewing and approving Quality Agreements, e.g. with distributor and other contracted parties
• Ensuring performance of Management Quality Reviews and establishment of Quality Metrics
• Hosting agency inspections related to the WDA
• Local GDP activities will be managed under your supervision and guidance.
• You will be expected to ensure up to date knowledge is maintained on relevant EU and local regulations as well as internal quality requirements. The role as Senior Specialist Quality Assurance may also include regional activities, such as support with regional SOPs and collaboration with Quality functions in other markets.

Required Education, Experience, and Skills

• Master of Science in Pharmacy or other life science Master’s degree (such as biology, medicine, chemistry)
• At least 2 years’ experience from a quality assurance position in the pharmaceutical industry.
• Strong leadership skills and problem-solving skills
• Excellent communication and prioritization skills
• Fluency in Danish and English