Senior QA Lead – Phase I/II Pharma Analytics & Cleaning

Alkermes; Boston (MA); On-site; USD 128,000 - 142,000; Full time

Benefits offered by this job

Annual performance pay bonus

Competitive benefits package

Job summary

Alkermes in Boston is seeking an experienced Quality Assurance professional to provide onsite support for Phase I/II manufacturing activities. The ideal candidate will ensure compliance with FDA/EU cGMP requirements and will be responsible for analytical lifecycle oversight, cleaning validation, and batch manufacturing support.

In this role, you will interact with regulatory bodies and will need a strong background in pharmaceutical development, with 10+ years of relevant experience. The position offers a competitive salary range of $128,000 to $142,000, along with an annual performance pay bonus.

Qualifications

• Minimum of 10 years' experience in the pharmaceutical industry.
• Strong background in cleaning validation and Quality Assurance.
• Ability to interact effectively during on-site audits.

Responsibilities

• Provide QA oversight for analytical lifecycle activities.
• Perform batch records and data review for disposition.
• Ensure compliance with cGMP and internal standards.

Skills

Strong communication skills

Knowledge of FDA and EU cGMPs

Problem-solving skills

Experience with Quality Management Systems

Ability to troubleshoot

Education

BSc. in a scientific discipline

Tools

Veeva

SAP

Job description

Alkermes in Boston is seeking an experienced Quality Assurance professional to provide onsite support for Phase I/II manufacturing activities. The ideal candidate will ensure compliance with FDA/EU cGMP requirements and will be responsible for analytical lifecycle oversight, cleaning validation, and batch manufacturing support.

In this role, you will interact with regulatory bodies and will need a strong background in pharmaceutical development, with 10+ years of relevant experience. The position offers a competitive salary range of $128,000 to $142,000, along with an annual performance pay bonus.