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Change Control Manager Jobs in Worcester, MA (NOW HIRING)

Medium

Associate Director, Quality Control

Waltham, MA · On-site

$160 - $200/hr

Manage phase appropriate stability, specification and reference standard programs in support of ... Provide QC oversight for OOS/OOT investigations, deviations, CAPAs, and change control * Review and ...

Replimune-2

Scientist I, Quality Control

Framingham, MA · On-site

$112.50 - $146/hr

The QC Analytical Scientist will assist in the management of the QC laboratory. It is expected that ... Responsible for change control, deviations and CAPA's related to QC Analytical operations including ...

Replimune

Scientist I, Quality Control

Framingham, MA · On-site

$112K - $146K/yr

The QC Analytical Scientist will assist in the management of the QC laboratory. It is expected that ... Responsible for change control, deviations and CAPA's related to QC Analytical operations including ...

Replimune Group

Scientist I, Quality Control

Framingham, MA · On-site

$112.50 - $146/hr

The QC Analytical Scientist will assist in the management of the QC laboratory. It is expected that ... Responsible for change control, deviations and CAPA's related to QC Analytical operations including ...

Replimune

Scientist II, Quality Control

Framingham, MA · On-site

$124K - $165K/yr

The QC Analytical Scientist will assist in the management of the QC laboratory. It is expected that ... Responsible for change control, deviations and CAPA's related to QC Analytical operations including ...

New

Gentuity

Quality Systems Manager

Sudbury, MA · On-site

Manage Document Control system, including the Change Order process. * Manage the CAPA, Complaints, SCAR, and Audit Findings processes. * Lead supplier management, including maintaining the Approved ...

Gentuity

Quality Systems Manager

Sudbury, MA

Manage Document Control system, including the Change Order process. Manage the CAPA, Complaints, SCAR, and Audit Findings processes. Lead supplier management, including maintaining the Approved ...

Curia, Inc.

QC Microbiologist II

Hopkinton, MA · On-site

$74K - $85K/yr

Initiate Quality events such as deviations, invalid assay investigations, CAPA and Change controls ... * Assist QC management to author, review and approve documentation. * Assist QC management to ...

AMRI

QC Microbiologist II

Hopkinton, MA

$74K - $85K/yr

Initiate Quality events such as deviations, invalid assay investigations, CAPA and Change controls ... * Assist QC management to author, review and approve documentation. * Assist QC management to ...

Gentuity LLC

Quality Systems Manager

Sudbury, MA · On-site

$145K - $165K/yr

... Control system, including the Change Order process. • Manage the CAPA, Complaints, SCAR, and Audit Findings processes. • Lead supplier management, including maintaining the Approved Supplier List ...

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All JobsChange Control JobsChange Control Manager JobsChange Control Manager Jobs in Worcester, MA

Change Control Manager information

See Worcester, MA salary details

$38.9K

$82K

$124.2K

How much do change control manager jobs pay per year?

As of Sep 7, 2026, the average yearly pay for change control manager in Worcester, MA is $81,956.00, according to ZipRecruiter salary data. Most workers in this role earn between $41,900.00 and $120,700.00 per year, depending on experience, location, and employer.

What is a change control manager?

Change Control Managers are professionals responsible for overseeing and managing the process of controlling changes to projects, systems, or processes within an organization. Their main role is to ensure that all proposed changes are properly evaluated, documented, and implemented in a controlled manner to minimize risks or disruptions. They work closely with project teams, stakeholders, and quality assurance to ensure compliance with regulatory requirements and organizational standards. This role is especially vital in industries like IT, pharmaceuticals, and manufacturing, where changes can significantly impact operations or product quality.

What are the typical challenges faced by a change control manager when coordinating cross-functional teams during change implementation?

A Change Control Manager often encounters challenges such as aligning diverse team priorities, ensuring clear communication, and managing resistance to change across departments. Coordinating cross-functional teams requires balancing the needs and schedules of stakeholders in IT, quality assurance, operations, and regulatory affairs. Successfully navigating these challenges involves setting transparent processes, hosting regular update meetings, and fostering a culture of collaboration to ensure changes are implemented smoothly and in compliance with relevant standards.

What are the key skills and qualifications needed to thrive as a change control manager, and why are they important?

To thrive as a Change Control Manager, you need expertise in project management, process improvement, and risk assessment, often supported by a relevant degree and certifications such as PMP or ITIL. Familiarity with change management software, documentation systems, and compliance tools is typically required. Strong communication, analytical thinking, and stakeholder management skills help drive successful change initiatives and mitigate resistance. These skills and qualities are crucial to ensure that organizational changes are implemented efficiently, with minimal disruption and maximum compliance.

What is the difference between Change Control Manager vs Quality Assurance Specialist?

AspectChange Control ManagerQuality Assurance Specialist
CertificationsISO 9001, PMP, or equivalentISO 9001, Six Sigma, or equivalent
Work EnvironmentRegulated industries like manufacturing, pharma, biotechManufacturing, software, healthcare sectors
Primary FocusManaging change processes, documentation, approvalsEnsuring product quality, testing, compliance

The Change Control Manager and Quality Assurance Specialist roles often overlap in regulated industries, but their focus differs. The Change Control Manager primarily oversees change processes and documentation, ensuring compliance with procedures. The Quality Assurance Specialist concentrates on maintaining product quality through testing and compliance checks. Both roles require similar certifications and work environments, but their core responsibilities distinguish them within the industry.

Are change control managers in demand?

Change Control Managers are in demand across industries such as pharmaceuticals, manufacturing, and technology, where regulatory compliance and process improvements are critical. Employers seek professionals with strong project management skills, knowledge of quality systems, and relevant certifications like CCMP or PMP to oversee change processes effectively.

What are popular job titles related to Change Control Manager jobs in Worcester, MA?

For Change Control Manager jobs in Worcester, MA, the most frequently searched job titles are:

What job categories do people searching Change Control Manager jobs in Worcester, MA look for?

The top searched job categories for Change Control Manager jobs in Worcester, MA are:

What cities near Worcester, MA are hiring for Change Control Manager jobs?

Cities near Worcester, MA with the most Change Control Manager job openings:

Change Control Manager jobs near you

Associate Director, Quality Control

Crescent Biopharma

Waltham, MA • Hybrid

$160K - $200K/yr

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

This job post has expired today. Applications are no longer accepted.

Key responsibilities

  • Oversee day-to-day QC activities and analytical testing at CDMOs and contract testing laboratories.

  • Manage stability, specification, and reference standard programs supporting early and late-stage products.

  • Ensure GMP compliance and proper documentation during release, stability, and in-process testing, including review of raw data and approval of stability reports.

Job description

Crescent Biopharma’s vision is to build a world leading oncology company bringing the next wave of therapies for cancer patients. The Company’s clinical-stage pipeline includes its lead program, a PD-1 x VEGF bispecific antibody, as well as novel antibody-drug conjugates. By leveraging multiple modalities and established targets, Crescent aims to rapidly advance potentially transformative therapies as single agents and as part of combination regimens to treat a range of solid tumors. For more information, visit www.crescentbiopharma.com and follow the Company on LinkedIn and X.

We are seeking an experienced Associate Director of Quality Control (QC) to lead QC operations across the company’s biologics pipeline.  You will report directly to the head of QC and will serve as key contributor in overseeing day-to-day QC activities and analytical testing at CDMOs and contract testing laboratories (CTLs). You must have deep expertise in stability, specification, reference standard programs management, analytical method transfer, qualification/validation. and a proven track record overseeing external testing labs in a GMP environment; you will also be responsible for ensuring robust, phase‑appropriate QC operations supporting Crescent’s biologics pipeline. This role is based in Waltham, MA and you must have experience in biotech.

Responsibilities
  • Manage phase appropriate stability, specification and reference standard programs in support of early and late-stage products 
  • Serve as QC point of contact for CDMOs/CTLs ensuring appropriate quality control oversight of manufacturing campaigns
  • Ensure CDMOs/CTLs perform release, stability and in-process testing in accordance with GMP requirements, Crescent standards, and regulatory expectations.
  • Generate COAs for intermediate material, Drug Substance/Drug Product and collaborate with QA to facilitate batch disposition
  • Monitor CDMO/CTL stability studies, review of raw data and approval of stability summary reports
  • Trend and evaluate stability data according to ICH in support of shelf life/expiry date assignment and extensions 
  • Schedule, chair and facilitate stability review board meetings in support of stability data evaluation and assignment of product shelf-life
  • Schedule, chair and facilitate stability review board in support of stability data evaluation and assignment of product shelf-life
  • Schedule, chair and facilitate specification review board in support of new product specification and revisions
  • Provide QC oversight for OOS/OOT investigations, deviations, CAPAs, and change control
  • Review and approve specific sections of vendor batch records and other required documentation
  • Collaborate with partners, CDMOs/CTLs to transfer, methods for release and stability testing as needed according to phase appropriate approach
  • Participate in the qualification, validation, and lifecycle management of analytical methods.
  • Support authoring and review of Module 3 sections of regulatory submissions (IND/IMPD/BLA).
  • Ensure strong data integrity practices and compliance with GMP, ICH, and global regulatory guidelines.
  • Assist in the establishment of QC systems, SOPs, and processes suitable for a lean and scalable operation.
  • Participate in internal and external cross-functional meetings as QC representative and manage program timelines
  • Provide leadership, mentoring, and technical development within the QC function.
Education & Experience
  • B.S. or M.S. in Biology, Chemistry, Biochemistry, Pharmaceutical Sciences, or related field.
  • Minimum 10 years of industry experience in biologics analytical development and QC.
  • Deep expertise in method qualification, validation, and lifecycle management.
  • Significant experience overseeing QC activities at CDMOs/CTLs.
  • Strong understanding of GMP, data integrity principles, and ICH analytical guidelines (Q2, Q5, Q6, Q1E).
  • Experience supporting Module 3 sections of regulatory submissions and interacting with health authorities.
  • Experience with bioassay (Binding ELISA and Cell Based Potency (CBA) method development and life cycle management is a plus.
  • Hands on experience using Microsoft Office, Veeva Vault QualityDoc, LIMS, and Statistical software such as GraphPad Prism, JMP.
  • Demonstrated ability to lead QC operations in a small or virtual biotech environment.
  • Strong communication, leadership, and cross‑functional collaboration skills.
What We Offer
  • Opportunity to join a mission-driven team where you'll contribute to impactful work, take on varied responsibilities, and grow quickly in a dynamic environment
  • Competitive compensation, including base salary, performance bonus, and equity
  • 100% employer-paid benefits package
  • Flexible PTO; also, two, one-week company-wide shutdowns each year
  • A commitment to your professional development, with access to resources, mentorship, and growth opportunities
Additional Description for Pay Transparency:
The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability. Subject to the terms of their respective plans, employees are eligible to participate in the Company’s savings plan (401(k)). This position is eligible to participate in the Company’s long-term incentive program. Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation – Unlimited PTO; Sick time – 10 days per calendar year; Holiday pay, including two Company shut downs; Parental Leave – 16 weeks within one year of the birth/adoption/foster care of a child; FMLA; Military Leave. Additional information can be found - https://www.crescentbiopharma.com/careers/#benefits
Crescent Biopharma is an Equal Opportunity Employer. We are committed to fostering a diverse, inclusive, and equitable workplace where all individuals are valued and respected. Employment decisions are based on qualifications, merit, and business needs, without regard to race, color, religion, gender, sexual orientation, national origin, disability, veteran status, or any other protected status.