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) β 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 US Offices around the country.
We are currently seeking a Quality AssuranceΒ Manager to join our team in Plainville, CT.Β
The ALK Plainville site, in Connecticut, is specializing in manufacturing of sterile injectable drug products. The QA Manager is responsible for ensuring the consistent implementation and oversight of Good Manufacturing Practices (GMP) in compliance with FDA, Health Canada, and other applicable regulatory requirements at the site. This position leads other quality professionals and plays a key role in maintaining and improving site compliance, supporting daily operations, and driving continuous quality improvement. The role requires strong leadership, excellent communication skills, and the ability to collaborate effectively across departments and sites.
The ideal candidate is a proactive βdoerβ who is hands-on, execution-focused, and experienced in driving Quality System improvements.Β
Primary Responsibilities:
The primary responsibilities for this position include:
- Ensure Site Compliance:Β Continuously safeguard product quality and regulatory compliance across the site, ensuring adherence to FDA, Health Canada, and other international regulatory standards.
- Team Leadership and Development:Β Lead, manage, and develop the QA team. Provide coaching, guidance, and performance feedback. Ensure training and development plans are adhered to aligned with company values and strategic goals.
- Quality System Oversight:Β Oversee key quality processes including deviations and CAPAs, change controls, batch and material release, Internal and external audits, complaint handling, training programs, SOP development and harmonization with Corporate SOPs (CSOPs), internal and external audits, computerized systems validation.
- Cross-Functional Collaboration:Β Partner with Manufacturing, QC, Validation, and Engineering teams to support production needs while ensuring compliance with cGMP and corporate standards. Represent QA in site management meetings and provide updates on quality performance and KPIs.
- Regulatory Inspection:Β Lead or actively support regulatory inspections (FDA, Health Canada, etc.) and implement corrective actions or initiatives in response to inspection findings or industry trends.
- Project and Integration Leadership:Β Drive, lead or execute projects to support compliance initiatives and integration activities into the existing quality framework. Harmonize processes including aseptic practices, validations, deviation investigations, room classification, and documentation systems.
- Documentation Review:Β Initiating and changing documentation within electronic quality systems. In depth review and approval of documents such as SOPs, analytical methods, protocols, system and equipment validation and qualification reports and investigations to ensure accuracy and compliance with cGMPs and company procedures.
- Compliance Monitoring and KPI Management:Β Monitor and report compliance metrics (KPIs) for the QA team and the site and ensure regular reviews to drive accountability and improvement.
- Communicates effectively and provides feedback on compliance issues to the QA Sr. Director.
- Work with QA Global to harmonize site SOPs with applicable Corporate SOPs (CSOPs).
- Willingness to gown and work in classified cleanroom environments as needed.
- Additional responsibilities as needed.
Experience & Skills:
- BS in Biology, Biochemistry, Chemistry, Microbiology, Pharmacy or other Life Sciences preferred.
- Minimum of 5 years of QA experience in a regulated pharmaceutical or biologics manufacturing environment.
- Strong knowledge of US FDA regulations (21 CFR Parts 210, 211, 11), Health Canada, ICH guidelines, and GXP principles (GMP, GDP, GLP).
- Experience supporting or leading regulatory inspections.
- Experience managing teams and developing talent.
- Experience with electronic quality management systems (e.g., Veeva, QAchange, SAP) and ability to work efficiently across multiple computer systems and platforms.Β
- Ability to provide clear direction, make confident decisions, and influence across departments.
- Strong communication and interpersonal skills.
- Able to work independently and within cross-functional teams in a fast-paced environment.
- Able to solve complex situations and problems
- Culture awareness and understanding the way of behavior in different cultures
Note:Β The ALK Plainville CT facility processesΒ penicillin. Those with confirmed allergy to penicillin should not apply.
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
- 13 company-paid holidays per year
Approximate annual salary range for this role: $100,000 to $110,000. This salary range is an estimate in good faith for the position. Final compensation can vary based on the candidate's relevant experience, skills, and knowledge.
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.