Senior Specialist, Quality Control (Change Control Lead)

United Pharma; Massachusetts; On-site; USD 120,000 - 155,000; Full time

Job summary

United Pharma in Massachusetts is seeking a seasoned Quality professional to own and execute GMP change controls across initiation to closure. You will collaborate with scientists, engineers, and QA leaders to ensure robust impact assessments and reliable documentation.

The role demands hands-on change control experience, GDP/Data Integrity knowledge, and the ability to drive risk-based decisions in a fast-moving environment.

Qualifications

• 5–8 years of pharmaceutical/biotech experience.
• Proven GMP change control lifecycle experience.
• Strong GDP and data integrity knowledge.

Responsibilities

• Own the Process: Drive the strategic development, governance, and end-to-end execution of QC change controls from initiation through implementation and closure.
• Be the SME: Represent QC Operations on local and global Change Control Boards and cross-functional forums.
• Champion Specifications: Manage lifecycle for clinical and commercial specifications; experience with specifications is a huge plus.
• Navigate Fast-Paced Growth: Anticipate risks, prioritize under pressure, pivot quickly as volume ramps up, and partner across teams to build effective mitigation strategies.
• Continuous Improvement: Spearhead process enhancements, streamline templates, and support technical writing for SOPs, methods, and controlled documentation.

Skills

Change Control

GxP Knowledge

Agility under pressure

Education

BS/BA in Life Sciences, Engineering, Regulatory, or related discipline

Job description

As the site expands its footprint, introduces new Automated Storage Units (ASUs), and scales operations, our Quality team is growing rapidly. You will step in as the true co-owner of the GMP Change Control process, ensuring seamless strategic execution, robust impact assessments, and reliable quality standards.

Here, your voice matters. You will work alongside passionate scientists, engineers, and quality leaders who celebrate innovation, continuous learning, and direct mentorship.

What You'll Be Doing

• Own the Process: Drive the strategic development, governance, and end-to-end execution of QC change controls from initiation through implementation and closure.
• Be the SME: Represent QC Operations on local and global Change Control Boards and cross-functional forums.
• Champion Specifications: Support documentation and lifecycle management for clinical and commercial specifications (experience with specifications is a huge plus!).
• Navigate Fast-Paced Growth: Anticipate risks, prioritize under pressure, pivot quickly as volume ramps up, and partner across teams to build effective mitigation strategies.
• Continuous Improvement: Spearhead process enhancements, streamline templates, and support technical writing for SOPs, methods, and controlled documentation.

What You Bring

• Education: BS/BA in Life Sciences, Engineering, Regulatory, or a related discipline.
• Experience: 5-8 years within the pharmaceutical or biotechnology sector.
• Change Control Expertise: Proven hands-on experience driving GMP change controls through complex lifecycles (experience handling changes for specifications is highly desirable).
• Agility & Drive: A proactive problem-solver who remains composed under pressure and enjoys dynamic, fast-moving laboratory and manufacturing support environments.
• GxP Knowledge: Strong foundation in GMP, Good Documentation Practices (GDP), and Data Integrity standards.