QC Manager

About ALK

ALK is a forward-thinking allergy company with a long tradition of allergy innovation. 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 with 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 offices North America.

We are currently looking for a Full-Time Quality Control Manager to join our teamin our Plainville , CT site. The QC Manager will work closely with other departments and must be able to collaborate effectively with others to ensure their quality control needs and specifications are met. This is a key position in our organization and the successful candidate must be able to communicate strategies clearly and effectively internally. The ideal candidate will be comfortable working in a fast-paced environment, can manage multiple site-specific projects, and feel comfortable leading when necessary.

Primary Responsibilities:

The primary responsibilities for this position include:

• Oversee daily QC operations in Chemistry and Microbiology laboratories, ensuring end-to-end compliance of incoming, in-process and routine operations and testing including environmental monitoring, water testing, stability, production, and incoming material release.
• Collaborate with other departments to resolve quality-related matters.
• Author, edit, review, and approve documents, including SOPs, work instructions, deviations, CAPAs, change controls, protocols, and environmental monitoring reports.
• Responsible for QC (Microbiology and Chemistry) administration, scheduling, and budgeting.
• Ensure compliance with regulatory standards and industry best practices (GxP).
• Oversee and adhere to global quality metric goals and plant metrics.
• Requisition and procurement of laboratory supplies related to QC laboratories and production support.
• Provide ILT (Instructor-Led Training) to QC team members on laboratory documents, including SOPs, WINs, and protocols - ensuring all staff are properly trained and qualified for assigned tasks.
• Provide support, leadership, and development of QC team members.
• Oversee plan and execution of product validation and stability studies, ensuring accurate data verification, reporting, and compliance with regulatory requirements.
• Ensure calibration, maintenance and operation of lab instrumentation, including balances, pH meter, UV/vis spectrophotometer, and other analytical equipment as necessary.
• Serve as primary subject matter expert during internal and external audits (e.g. FDA, Health Canada, Notified Body, and supplier audits).
• Foster a culture of quality and continuous improvement within the team and other departments.
• Other duties as assigned.

Skills and Experience:

• BS / BA in life sciences, biology, chemistry or related field preferred
• This position requires minimum 5 years of progressive management experience in a laboratory setting with increasing responsibilities in Pharmaceutical or GMP environment.
• Knowledge of current Good Manufacturing Practices (cGMP), USP, FDA and ICH guidelines is required.

Why ALK?

At ALK, we believe in providing an environment and culture in which our people can thrive, develop, and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance.

ALK offers:

• Excellent benefits including medical, dental, and vision
• 401(k) plan with generous employer contribution
• 12 company-paid holidays per year

ALK is an Equal Employment Opportunity / Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.