Top 716 Senior quality specialist Jobs in Burlington Ma

Senior Quality Assurance Specialist (CMC)
Anika Therapeutics —Bedford, MA
- $84,000 - $105,000 a year
- Full-time
- 5 years
- Analysis skills
- Senior level
- Health savings account
- Employee stock purchase plan
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Senior Manager, Regulatory Affairs NAM
Straumann —Andover, MA
- Up to $145,000 a year
- Full-time
- 5 years
- Office
- Analysis skills
- Health insurance
- Dental insurance
Engineering Specialist (DevOps) Lead
Fresenius Kabi —North Andover, MA
- $170,000 - $180,000 a year
- Full-time
- Hybrid work
- Background check
- Azure
- DevOps
- Wellness program
- Paid holidays
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QUALITY ASSURANCE DIRECTOR
Flik Hospitality Group —Boston, MA
- $108,000 - $110,000 a year
- Full-time
- Background check
- 5 years
- Bachelor's degree
- Commuter assistance
- Paid parental leave
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Associate Veterinarian
Atlas Consultancy Group —Boston, MA
- $150,000 - $190,000 a year
- Full-time
- Surgery
- Patient care
- In-person
- Relocation assistance
- Health insurance
Quick Apply
BIM Revit Specialist
PowerHawke, Inc. —Boston, MA
- Full-time
- Background check
- AutoCAD
- Mid-level
- Health savings account
- Health insurance
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HR Operations Specialist (CONTRACT)
TransMedics, Inc. —Andover, MA
- Full-time
- Mid-level
- Office
- Administrative experience
- Employee stock purchase plan
- Disability insurance
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Data Collection Specialist
Communication Technology Services (CTS) —Marlborough, MA
- Weekends as needed
- Clean driving record
- Construction site
- Basic math
5d
Manager or Senior Manager, Strategic Corporate Tax
KPMG —Boston, MA
- Full-time
- CPA
- 5 years
- Office
- Disability insurance
- Health insurance
11d
LPN
The Delaney at the Vale —Woburn, MA
- $40 an hour
- Full-time
- Hospitality
- LPN
- Entry level
- Health insurance
- Dental insurance
Senior Associate, Insurance Tax
KPMG —Boston, MA
- Full-time
- Mid-level
- Bachelor's degree
- Team management
- Disability insurance
- Health insurance
Regional Compliance Specialist (Quincy Regional Office/Northeast Region)
WinnCompanies —Quincy, MA
- $80,000 - $92,000 a year
- Weekends as needed
- Management
- 5 years
- English
- Health savings account
- AD&D insurance
Quick Apply
Manheim Vehicle Condition Inspector, Concord, MA ($2,000 sign on bonus)
Cox Automotive —Massachusetts
- $18.22 - $32.79 an hour
- Clean driving record
- Dealership
- Customer service
- Paid jury duty
- Paid holidays
Quick Apply
Caregiver
The Delaney at the Vale —Woburn, MA
- From $20 an hour
- Part-time
- Vital signs
- High school diploma or GED
- CNA
- Health insurance
- Dental insurance
Consultant - Corporate Finance - Healthcare
Berkeley Research Group, LLC —Boston, MA
- Full-time
- CPA
- Mid-level
- Office
10d
Senior Managing Consultant - Corporate Finance - Healthcare
Berkeley Research Group, LLC —Boston, MA
- Full-time
- CPA
- Office
- Analysis skills
10d
Senior Associate - Corporate Finance - Turnaround & Restructuring
Berkeley Research Group, LLC —Boston, MA
- $80,000 - $135,000 a year
- Full-time
- Microsoft Word
- CPA
- Research
10d
Consultant - Corporate Finance - Turnaround & Restructuring
Berkeley Research Group, LLC —Boston, MA
- $90,000 - $160,000 a year
- Full-time
- Microsoft Word
- CPA
- Mid-level
10d
Consultant - Corporate Finance - Turnaround and Restructuring
Berkeley Research Group, LLC —Boston, MA
- Full-time
- Microsoft Word
- CPA
- Mid-level
10d
Consultant - Corporate Finance - Turnaround and Restructuring
Berkeley Research Group, LLC —Boston, MA
- $90,000 - $160,000 a year
- Full-time
- Microsoft Word
- CPA
- Mid-level
3d

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senior quality specialist jobs near burlington ma

Senior Quality Assurance Specialist (CMC)

Anika Therapeutics -
Bedford, MA

Quick Apply

Job Details

Full-time
$84,000 - $105,000 a year

Benefits

Health savings account
Employee stock purchase plan
Health insurance
401(k)
Paid time off

Qualifications

Communication with suppliers
Investigations regulatory compliance
Document control experience within pharmaceutical industry
ICH Q7
Drug regulation
Production deviation management
Quality control preventive actions
Corrective and preventive actions (CAPA)
ICH Q9
Pharmaceutical company experience
Quality assurance experience within pharmaceutical industry
ICH Q10
Regulatory/legal compliance standards in production
Collaboration with manufacturing teams
Biomedical regulatory compliance
Quality control experience within pharmaceutical industry
Cross-functional communication
Supplier quality assurance (SQA)
FDA regulations
Pharmaceutical manufacturing facility experience

Full Job Description

What You’ll Do

The Senior Quality Assurance Specialist provides quality assurance oversight across CMC development, Quality Control, Analytical Development, manufacturing, and supply chain activities, ensuring compliance with global regulatory requirements and internal quality standards. In this role, you serve as a subject matter expert in GMP quality systems, CMC quality oversight, and regulatory inspection readiness while supporting the successful advancement of development and commercial programs.

How You’ll Contribute

Provide quality oversight for GMP manufacturing activities across drug substance and drug product operations, including external manufacturing partners and CDMOs.
Review and approve GMP documentation, including batch records, SOPs, protocols, validation reports, stability reports, investigations, and other quality records to ensure compliance with applicable regulations and company requirements.
Support batch disposition activities and ensure products are manufactured, tested, and released in accordance with cGMP requirements.
Partner with CMC, Technical Operations, and cross-functional teams to support technology transfer, process scale-up, process validation, and manufacturing readiness activities.
Ensure timely initiation, investigation, closure, and effectiveness monitoring of deviations, CAPAs, and change controls.
Identify and communicate quality risks while partnering with stakeholders to implement practical and compliant mitigation strategies.
Support implementation, maintenance, and continuous improvement of Quality Management System (QMS) processes, including deviations, CAPA, change control, document control, training, and quality risk management.
Assess quality systems and processes against FDA, EMA, ICH, and other applicable regulatory expectations and drive inspection-ready improvements.
Develop, revise, and maintain quality procedures and standard operating procedures that support compliance while enabling efficient business operations.
Support internal audits, supplier audits, and CDMO audits to assess compliance and identify opportunities for continuous improvement.
Drive inspection readiness activities through gap assessments, mock inspections, documentation reviews, and focused remediation efforts.
Draft, review, and support responses to audit observations, supplier findings, and regulatory inspection outcomes.
Maintain consistency, traceability, and integrity across quality systems, documentation, and GMP records.
Perform other duties and projects as assigned.

What It Takes

This position operates in a dynamic and highly regulated pharmaceutical environment where effective quality oversight is critical to product quality, patient safety, regulatory compliance, and business success. The role requires sound judgment, strong analytical skills, and the ability to balance compliance requirements with operational objectives. Success requires the ability to independently evaluate complex quality issues, collaborate effectively across multiple functions and external partners, and drive practical solutions that maintain regulatory compliance while supporting program execution.

What You Bring

Bachelor’s degree in Chemistry, Pharmaceutical Sciences, Engineering, or a related scientific discipline; advanced degree preferred.
Minimum of 5 years of Quality Assurance experience within the biotechnology or pharmaceutical industry operating under GMP regulations.
Strong working knowledge of FDA and EMA cGMP regulations and applicable ICH guidelines, including Q7, Q8, Q9, and Q10.
Experience supporting pharmaceutical manufacturing operations and providing quality oversight of suppliers, contract manufacturers, and CDMOs.
Experience reviewing and approving GMP documentation, investigations, deviations, CAPAs, change controls, and validation-related documentation.
Working knowledge of Quality Management Systems and regulatory inspection readiness practices.
Strong written and verbal communication skills with the ability to effectively collaborate across functional teams and external partners.

Nice to Have

Advanced degree in a scientific, engineering, or related discipline.
Experience supporting CMC development activities, analytical development programs, and technology transfer initiatives.
Thorough understanding of pharmaceutical and medical device Quality Management Systems.
Experience supporting regulatory inspections and responding to audit observations and regulatory findings.
Knowledge of process validation, cleaning validation, and pharmaceutical manufacturing lifecycle activities.
Experience working in both commercial-stage and development-stage GMP environments.
Demonstrated ability to drive continuous improvement initiatives and implement pragmatic, risk-based quality solutions.

The salary range provided is based on the Company’s reasonable estimate of the base salary pay range for this position at the time of posting. Actual base pay is determined by several factors relevant to the position, including skills, competencies, experience, education, and geographic location. Anika also offers a discretionary bonus program for all full-time employees, comprehensive healthcare benefits, health savings account, 401(k) plan with up to 5% company match which includes immediate vesting, employee stock purchase plan at a 15% discount, accrued paid time off, additional long-term incentives including stock awards, and much more. At Anika, we take pride in offering robust Total Rewards, inclusive of market-leading benefits to meet our employees where they are in their career and in life.

The compensation and benefits information is provided as of the date of this posting. Anika reserves the right to modify compensation and benefits at any time, subject to applicable law.

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Refine Your Search

senior quality specialist jobs in burlington ma

Senior Quality Assurance Specialist (CMC)

Senior Manager, Regulatory Affairs NAM

Engineering Specialist (DevOps) Lead

QUALITY ASSURANCE DIRECTOR

Associate Veterinarian

BIM Revit Specialist

HR Operations Specialist (CONTRACT)

Data Collection Specialist

Manager or Senior Manager, Strategic Corporate Tax

LPN

Senior Associate, Insurance Tax

Regional Compliance Specialist (Quincy Regional Office/Northeast Region)

Manheim Vehicle Condition Inspector, Concord, MA ($2,000 sign on bonus)

Caregiver

Consultant - Corporate Finance - Healthcare

Senior Managing Consultant - Corporate Finance - Healthcare

Senior Associate - Corporate Finance - Turnaround & Restructuring

Consultant - Corporate Finance - Turnaround & Restructuring

Consultant - Corporate Finance - Turnaround and Restructuring

Consultant - Corporate Finance - Turnaround and Restructuring

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