1

Iso Manager Jobs in Needham, MA (NOW HIRING)

Collaborate with R&D and process development teams to ensure product performance, scalability, and regulatory compliance (e.g., GMP, ISO). * Manage product lifecycle from concept through launch and ...

Senior Product Manager

Waltham, MA · On-site

$135K - $209K/yr

Collaborate with R&D and process development teams to ensure product performance, scalability, and regulatory compliance (e.g., GMP, ISO). * Manage product lifecycle from concept through launch and ...

Senior Product Manager

Waltham, MA · On-site

$135 - $209/hr

Collaborate with R&D and process development teams to ensure product performance, scalability, and regulatory compliance (e.g., GMP, ISO). * Manage product lifecycle from concept through launch and ...

Senior Product Manager

Waltham, MA · On-site

$135 - $209/hr

... ISO).Manage product lifecycle from concept through launch and post-market optimization, including phase-out strategies.Commercial Enablement & GrowthPartner with marketing and sales to develop go-to ...

ISO Standards - which includes: * 1. ISO Implementation * 2. ISO Consultation * 3. ISO ... Service Management Systems (SMS), * 8.Business Continuity Management Systems (BCMS), * 9.

ISO Standards - which includes: * 1. ISO Implementation * 2. ISO Consultation * 3. ISO ... Service Management Systems (SMS), * 8.Business Continuity Management Systems (BCMS), * 9.

Lead and manage the Quality function, maintaining ISO 9001 certification through a continuous improvement approach. * Oversee and analyze key quality metrics, including warranty data, customer issues ...

... ISO Certification -Second sector: Software Development * 1.Developing applications for all technologies and platforms * 2.Enterprise Resource Planning (ERP), * 3.Customer Relationship Management ...

Lead and manage the Quality function, maintaining ISO 9001 certification through a continuous improvement approach. * Oversee and analyze key quality metrics, including warranty data, customer issues ...

Lead and manage the Quality function, maintaining ISO 9001 certification through a continuous improvement approach. * Oversee and analyze key quality metrics, including warranty data, customer issues ...

Lead and manage the Quality function, maintaining ISO 9001 certification through a continuous improvement approach. * Oversee and analyze key quality metrics, including warranty data, customer issues ...

... ISO Certification -Second sector: Software Development * 1.Developing applications for all technologies and platforms * 2.Enterprise Resource Planning (ERP), * 3.Customer Relationship Management ...

Provide general oversight of SharkNinja's Quality Management System for medical devices, ensuring it remains effective, audit-ready, and aligned with applicable standards (e.g., ISO 13485, FDA 21 CFR ...

Ensure compliance with FDA, MDSAP, IVDR, ISO, and other applicable regulatory requirements and harmonized standards. * Oversee the management of documentation, records, test reports, deviations ...

next page

Showing results 1-20

Iso Manager information

See Needham, MA salary details

$30K

$89K

$149.8K

How much do iso manager jobs pay per year?

As of Aug 29, 2026, the average yearly pay for iso manager in Needham, MA is $88,976.00, according to ZipRecruiter salary data. Most workers in this role earn between $54,500.00 and $126,900.00 per year, depending on experience, location, and employer.

What is an ISO manager?

An ISO Manager is a professional responsible for overseeing the implementation and maintenance of ISO (International Organization for Standardization) standards within an organization. Their primary duties include ensuring compliance with relevant ISO standards, conducting internal audits, and leading the process for certification or recertification. ISO Managers work to improve organizational processes, train staff on quality management systems, and liaise with external auditors. They play a crucial role in helping organizations achieve and maintain high standards of quality, safety, and efficiency.

What are the key skills and qualifications needed to thrive as an ISO manager, and why are they important?

To thrive as an ISO Manager, you need in-depth knowledge of ISO standards (such as ISO 9001, 14001, or 27001), quality management principles, and relevant industry regulations, usually backed by a degree in a related field and ISO Lead Auditor certification. Familiarity with audit management tools, document control systems, and compliance software is typically required. Strong analytical thinking, attention to detail, and effective communication skills help in leading teams, facilitating audits, and driving continuous improvement. These skills ensure robust compliance, foster a culture of quality, and help organizations maintain certifications critical for credibility and operational excellence.

What are some common challenges faced by ISO managers when implementing new quality management systems, and how can they be overcome?

ISO Managers often encounter resistance to change from staff when introducing new quality management systems, as well as difficulties in aligning existing processes with ISO standards. To overcome these challenges, it's important to foster open communication, provide thorough training, and involve team members early in the process. Additionally, collaborating closely with department heads helps ensure that each area understands the benefits and requirements of compliance, making the transition smoother and more sustainable.

What is the difference between Iso Manager vs Quality Assurance Specialist?

AspectIso ManagerQuality Assurance Specialist
CertificationsISO Lead Auditor, ISO 9001/14001/45001 certificationsISO 9001 Internal Auditor, CQE, CQA certifications
Work EnvironmentManufacturing, industrial, corporate quality departmentsManufacturing, service, healthcare sectors
Employer & Industry UsageCompanies implementing ISO standards, compliance teamsOrganizations focusing on quality control, process improvement

While both roles focus on quality and standards, the Iso Manager primarily oversees ISO compliance and certification processes, ensuring organizational adherence to international standards. The Quality Assurance Specialist concentrates on product quality, testing, and process improvements within various industries. Understanding these differences helps in selecting the right career path or job role based on your expertise and industry focus.

What job categories do people searching Iso Manager jobs in Needham, MA look for?

The top searched job categories for Iso Manager jobs in Needham, MA are:

What cities near Needham, MA are hiring for Iso Manager jobs?

Cities near Needham, MA with the most Iso Manager job openings:

Infographic showing various Iso Manager job openings in Needham, MA as of August 2026, with employment types broken down into 82% Full Time, 15% Part Time, 2% Temporary, and 1% Contract. Highlights an 79% Physical, 3% Hybrid, and 18% Remote job distribution, with an average salary of $88,976 per year, or $42.8 per hour.

Senior Product Manager

Repligen

Waltham, MA

$135K - $209K/yr

Full-time

Medical, Dental, Vision, Retirement, PTO

Posted 14 days ago


Repligen rating

7.6

Company rating: 7.6 out of 10

Based on 13 frontline employees who took The Breakroom Quiz


Job description

We are seeking a scientifically driven and commercially savvy Senior Product Manager to lead all aspects of product commercialization and product lifecycle management for the affinity ligands and chromatography resin portfolio. This role is critical to driving innovation, market expansion and customer success, supporting biopharmaceutical manufacturing, protein purification, and downstream processing applications, within our Chromatography business unit portfolio. You will collaborate with R&D, manufacturing, regulatory, and commercial teams to deliver high-performance solutions that meet the evolving needs of biologics developers and manufacturers.

Key Responsibilities:

Strategic Product Leadership

  • Define and execute the product roadmap for affinity ligands and chromatography resins, aligned with market trends and customer needs in bioprocessing.
  • Conduct market analysis and engage with key opinion leaders to identify opportunities for innovation and differentiation.
  • Develop business cases for new product development, including resin formats, ligand technologies, and application-specific solutions

Product Development & Lifecycle Management

  • Translate voice of customer and market research into new product opportunities
  • Collaborate with R&D and process development teams to ensure product performance, scalability, and regulatory compliance (e.g., GMP, ISO).
  • Manage product lifecycle from concept through launch and post-market optimization, including phase-out strategies.

Commercial Enablement & Growth

  • Partner with marketing and sales to develop go-to-market strategies, technical content, and training materials.
  • Lead pricing, positioning, and promotional campaigns tailored to different customer segments
  • Monitor product performance, customer feedback, and competitive landscape to drive continuous improvement.

Cross-Functional Collaboration

  • Serve as the internal expert on the chromatography business, supporting commercial activities and customer engagements.
  • Work closely with quality, and supply chain teams to ensure product availability, quality, compliance and operational excellence.
  • Represent the product line at industry conferences, webinars, and customer meetings.
Education and Work Experience Requirements:
  • Bachelor's or advanced degree in Biochemistry, Chemical Engineering, Biotechnology, or related field (MBA preferred).
  • 7+ years of product management experience in life sciences, with a focus on chromatography, purification technologies, or bioprocessing.
  • 2-3+ years of direct report management experience
  • Good understanding of chromatography and downstream processing workflows
  • Experience working in regulated environments (e.g., GMP, ISO 9001).
  • Strong analytical, communication, and leadership skills.
  • Proficient in MS Office Suite (Word, Excel, PowerPoint, Project and Visio)
  • Customer facing experience and the ability to build mutually beneficial, trusting relationships with internal and external stakeholders
  • Strong attention to detail with excellent verbal and written communication skills
  • Ability to take initiative, hold team members accountable for deliverables, and obtain support across functions
  • Strategic, tactical and analytical thinking
  • Ability to travel globally, up to 25%
Our mission is to inspire advances in bioprocessing as a trusted partner in the production of biologic drugs that improve human health worldwide. Focused on cost and process efficiencies, we deliver innovative technologies and solutions that help set new standards in bioprocessing. The estimated base salary range for this role, based in the United States of America is $135,000-$209,000. Compensation decisions are dependent on several factors including, but not limited to an individual's qualifications, location, internal equity, and alignment with market data. Additionally, employees are eligible to participate in one of our variable cash programs (bonus or commission) and eligible roles may receive equity as part of the compensation package. We offer a wide range of benefits such as paid time off, health/dental/vision, retirement benefits and flexible spending accounts. All compensation and benefits information will be confirmed in writing at the time of offer.

What Repligen employees say

Pay

Benefits

Hours and flexibility

Workplace

Get the full story on Breakroom