Quality Assurance Operations Manager

ALK Published: March 14, 2019
Port Washington, NY
Job Type


Position: Quality Assurance Operations Manager

About ALK

ALK is a forward-thinking allergy company with a long tradition for allergy innovation. We are making a bold move into digital to transform the way consumers, patients, and healthcare professionals address allergies. ALK is devoted to improving quality of life for people with allergies by developing pharmaceutical products that target the actual cause of allergy. ALK is the world leader in allergy vaccination (immunotherapy) – a unique treatment that induces a protective immune response which reduces and potentially halts the allergic reaction.

Since 1923, we have been working to improve the quality of life for allergy patients by developing products that target the cause of allergy. With over 2,200 employees and subsidiaries, production facilities and distributors worldwide we are in a unique position to further the advancement of allergy treatments. The company is publicly traded on NASDAQ OMX Copenhagen (OMX: ALKB) with global headquarters in Horsholm, Denmark and US Offices in Round Rock, TX, Bedminster, NJ, Port Washington, NY, Post Falls, Idaho, Luther, OK, Oklahoma City, OK and Mississauga, Canada.

ALK has an opening for a full-time QA Operations Manager, located in our Port Washington, NY facility.

Position Responsibilities:  Responsible for quality within NY production operations (QA Materials Release and Batch Release.)  These responsibilities include:

·         Continuously safeguarding quality and compliance (e.g. FDA) in production areas so that ALK will always fulfill official requirements for the production of pharmaceutical products

·         Maintaining QA oversight throughout NY production operations and QA operations functions, assuring clear roles and responsibilities in all QA Operations areas

·         Batch Record Review

·         QA Materials Receiving

·         Monitoring and following up on Product Quality in the QA Operations group

·         Ensuring that health authority requirements and trends are monitored and implemented, with special focus on quality assurance and compliance

·         Managing the work of QA Operations group and ensuring team effort

·         Working with other managers in the company to establish best practices and alignment to SOPs throughout North America

·         Reinforcing quality standards and performance


·         BS in Biology, Biochemistry, Chemistry or life sciences or equivalent


·         Minimum 5 years of experience in the pharmaceutical industry within quality, manufacturing, product development and/or regulatory affairs

·         5-7 years management experience

·         Pharmaceutical and medical device business understanding, including in-depth knowledge about regulatory and GMP requirements

ALK is an equal opportunity employer with competitive pay and excellent benefits including medical, dental, vision coverage, life and disability insurance, 401k plan with employer contribution, 12 company paid holidays per year, and up to 2 weeks' paid time off in the first year of employment with the company!

Equal Opportunity Employer Veterans/Disabled



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