Quality Assurance Manager (Quality Responsible Person) Germany

Job Description

Organon is looking for an Quality Assurance Manager Germany (Quality Responsible Person), who will be a key player in the local affiliate in ensuring compliance with external and internal requirements pertaining to wholesaling and distribution activities.

You will hold the role as Quality Responsible Person (QRP) for the Wholesale Distribution Authorization (WDA) for our company in Germany and will also be responsible for the QMS for the Austrian market. In this role you will be overall responsible for local quality activities and your primary objective is to secure compliance with regards to quality, safety and Good Distribution Practices. You will have the opportunity to interact with a broad spectrum of internal and external stakeholders including internal management functions and local Health Authorities. The responsibilities of the QRP include an authority to act and take decisions to fulfill agency requirements and to safeguard patient health.

This role sits within the Quality organization yet has a truly cross-collaborative blend with the many day to day collaborations with multiple stakeholders across other functions within the company.

Responsibilities:

• "Quality Responsible Person" according to § 52a AMG in conjunction with AM-HandelsV

• Being the primary point of contact for local Health Authorities with regards to quality matters

• Ensuring fulfillment with applicable local and EU regulations around Good Distribution Practice of medicinal products for human use as well fulfillment of applicable regulations around Medical Devices.

• 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

• 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 may also include regional activities, such as support with regional SOPs and collaboration with Quality functions in other markets.

Required Education, Experience, & Skills:

• Master of Science in Pharmacy or other life science Master’s degree (such as biology, medicine, chemistry)

• Solid experience from a quality assurance position in the pharmaceutical industry.

• Previous experience of holding a position as Quality Responsible Person or deputy

• Solid experience in interacting with Health Authorities

• Strong leadership skills and problem-solving skills

• Excellent communication and prioritization skills

• Fluency in German and English

More on the Organon Quality Organization:

Our Quality organization ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed in alignment with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

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