Qa Compliance Manager

ALK-Abelló

Hørsholm

On-site

DKK 900,000 - 1,200,000

Full time

2 days ago

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Job summary

ALK-Abelló is seeking a QA Compliance Manager to support Global Quality in managing external partnerships and promoting cross-functional collaboration. The role is based at ALK headquarters in Hørsholm, Denmark, with international travel about 20 days per year.

The position focuses on Partner Quality Agreements, coordination of partner relations, and driving quality processes across regions including the USA, Japan, EU, Australia, and Southeast Asia.

Qualifications

Master’s degree in natural sciences, pharmacy, or a related field.
5+ years of experience in the pharmaceutical industry, preferably within Quality and Manufacturing.
Experience with quality management systems, processes and tools.
Prior experience with Quality Agreements, as well as external and internal negotiations, is highly desirable.
Demonstrated operational or project management skills and able to drive collaboration and process implementation without direct reports.

Responsibilities

Serve as the primary contact for Partner Quality Agreements and activities involving external partners and handling challenges as they arise (investigations, complaints and changes).
Communication, coordination and management of Partner relations.
Manage day-to-day inquiries from external partners.
Develop, drive, optimize and maintain efficient Quality business processes between ALK and Partners.
Negotiation, draft and update Quality agreements with Partners in regions such as USA, Japan, EU, Australia, Southeast Asia etc.
Communicate and coordinate implementation and training of Partner Quality Agreements within ALK.
Support and participate in activities related to inspection and audits performed by regulatory authorities or partners related to International markets at ALK Product Supply sites.
Manage stakeholder relationships and facilitate meetings both internally at ALK and with external Partners across various time zones.

Skills

Quality management systems

Quality Agreements

Negotiations

Project management

Cross-functional collaboration

Education

Master’s degree in natural sciences, pharmacy, or related field

Job description

Looking to advance your career in a global pharmaceutical company specializing in allergy treatments? Join ALK and become part of our mission to help people living with allergies worldwide!

We're seeking a highly motivated QA Compliance Manager to support our Quality Leadership in managing external partnerships and promoting cross-functional collaboration within ALK.

The position

As a QA Compliance Manager within Global Quality, you will join a passionate and experienced team overseeing a variety of quality tasks, processes, and systems across multiple GxP areas. You will be instrumental in enhancing global Quality Management and ensuring efficient operations throughout ALK’s organizational structure—with the opportunity to collaborate both internally and with external partners in the USA, Japan, Southeast Asia, and beyond. You will be located in ALK headquarters, Hørsholm, Denmark

International travel is expected (approx. 20 days/year).

Your primary responsibility areas and tasks will be:

Serve as the primary point of contact for Partner Quality Agreements and activities involving external partners and handling challenges as they arise (investigations, complaints and changes).
Communication, coordination and management of Partner relations.
Manage day-to-day inquiries from external partners.
Develop, drive, optimize and maintain efficient Quality business processes between ALK and Partners
Negotiation, draft and update Quality agreements with Partners in regions such as USA, Japan, EU, Australia, Southeast Asia etc.
Communicate and coordinate implementation and training of Partner Quality Agreements within ALK.
Support and participate in activities related to inspection and audits performed by regulatory authorities or partners related to International markets at ALK Product Supply sites.
Manage stakeholder relationships and facilitate meetings both internally at ALK and with external Partners across various time zones.

Your profile

We expect that you have the following qualifications:

Master’s degree in natural sciences, pharmacy, or a related field.
Over 5 years of experience in the pharmaceutical industry, preferably within Quality and Manufacturing.
Experience with quality management systems, processes and tools.
Prior experience with Quality Agreements, as well as external and internal negotiations, is highly desirable.
Demonstrated operational or project management skills and able to drive collaboration and process implementation without direct reports.

Personal characteristics:

Proactive and self-driven, with a high level of initiative.
Energetic facilitator and coordinator who also enjoys operational hands-on work and tasks.
Skilled in building relationships and working respectfully across different cultures.
Excellent cross-cultural communicator with verbal and written Danish & English.
A strong quality mindset, with a consistent commitment to maintaining a high standard in all quality-related processes.
Able to work independently as well as a strong team player.

Become a part of ALK

We offer an attractive working environment for individuals looking for both personal and professional development. ALK is a global pharmaceutical company specializing in allergy immunotherapy. We are driven by a high level of professionalism, integrity, an open-minded approach and contributing to an inspiring and fun working environment together with our colleagues. You will be part of an engaged and informal team who values skill and knowledge creation. The result of your efforts will be significant throughout the organization, and you will be able to actively influence and challenge the status quo.

Our offices in Denmark offer a green view of the DTU Science Park in Hørsholm. We believe that physical presence enforces strong teamwork and collaboration and creates success, so it is important that you enjoy coming to work at our site with a degree of flexibility to also work from home.

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