Site Quality Lead

Department: Quality • Location: Newburyport, MA

About the role

The Site QA Lead is responsible for leading all Quality Assurance operations and implementing & maintaining the effectiveness of the site's Quality Management System (QMS). This role serves as the senior quality leader for the facility and provides strategic and tactical leadership to ensure compliance with customer, regulatory, and company requirements while driving a culture of continuous improvement.

Responsibilities

• Quality Leadership
  • Serve as the senior quality leader for the site and a member of the site leadership team.
  • Develop, communicate, and execute the site's quality strategy and objectives.
  • Promote a culture of quality, compliance, accountability, and continuous improvement throughout the organization.
  • Partner effectively with Operations, Supply Chain, Commercial, R&D, Engineering, EH&S, and Corporate Quality functions.
  • Execute resource management within the Quality Organization as needed.
• Quality Management System
  • Own and maintain the site's Quality Management System.
  • Ensure compliance with applicable quality standards, customer requirements, and company procedures.
  • Manage document control, training compliance, change management, deviations, nonconformances, CAPA, risk assessments, and management review processes.
  • Establish metrics and dashboards to monitor QMS effectiveness and drive improvements.
• Audit and Compliance Management
  • Lead all customer, regulatory, certification, and corporate quality audits.
  • Own remediation and sustainability of corrective actions resulting from recent six-system audit findings.
  • Develop and implement a site-wide internal audit program, including auditor qualification, audit scheduling, execution, reporting, and effectiveness verification.
  • Ensure audit readiness across all departments and functions.
• CAPA and Continuous Improvement
  • Lead root cause investigations and corrective/preventive action programs.
  • Ensure timely closure and effectiveness verification of quality actions.
  • Drive continuous improvement initiatives focused on process performance, compliance, data integrity, and customer satisfaction.
  • Utilize risk-based decision making and quality metrics to identify improvement opportunities.
• Quality Operations
  • Manage daily Quality Assurance activities supporting manufacturing and product release.
  • Provide oversight of batch record review, product disposition, change controls, deviations, and investigations, as applicable.
  • Ensure quality requirements are integrated into manufacturing and support processes.
  • Support introduction of new products and technology transfers while maintaining quality compliance.
• People Leadership
  • Lead, coach, and develop Quality personnel.
  • Establish performance expectations and support ongoing employee development.
  • Build organizational capability through training, mentoring, and succession planning.
  • Foster cross-functional collaboration and quality ownership throughout the site.
• Customer and Regulatory Interface
  • Serve as the primary site representative for customer quality matters.
  • Manage customer complaints, responses, investigations, and quality questionnaires.
  • Support customer visits and quality-related business development activities.
  • Maintain productive relationships with regulatory agencies, certification bodies, and key customers.
• Safety, Health & Environmental Compliance
  • Champion safe work practices and ensure compliance with all applicable EH&S requirements.
  • Support site initiatives that promote operational excellence and safe manufacturing practices.
  • Participate as a member of the site leadership team in achieving overall business objectives.

Requirements

• Bachelor's degree in Chemistry, Chemical Engineering, Engineering, Life Sciences, or related technical discipline.
• 7-10+ years of progressive experience in Quality Assurance, Quality Systems, or Quality Management within a chemical, pharmaceutical, life science, specialty materials, or regulated manufacturing environment with a focus on QMS implementation and continuous improvement.
• Minimum 5 years of leadership experience managing quality personnel and quality systems.
• Strong working knowledge of Quality Management Systems, internal auditing, CAPA, investigations, and quality compliance programs.
• Experience leading customer, corporate, and/or certification audits.
• Demonstrated success implementing sustainable quality system improvements.
• Excellent communication, leadership, project management, and problem-solving skills.

Preferred Qualifications

• Experience in cGMP, API, specialty chemical, electronic materials, CDMO, or highly regulated manufacturing environments.
• Certified Quality Auditor (CQA), Certified Manager of Quality/Organizational Excellence (CMQ/OE), or equivalent certification.
• ISO 9001 or other certified quality systems auditing and quality systems experience.
• Lean Six Sigma certification or demonstrated continuous improvement experience.
• Experience addressing regulatory observations and leading site-wide remediation programs.

Pay

Hiring salary range: $140,000 - $170,000 annualized. This is a full-time, exempt position not eligible for overtime compensation.

Eligible to participate in the 2026 Ascensus Bonus Plan (ABP) at a target of 10% of base annual wage. Bonus potential is prorated for new hires based on hire date.

Benefits

• Health & Wellness
  • Comprehensive Medical, Dental, and Vision insurance plans.
  • Life and AD&D insurance.
  • Short-term/Long-term Disability coverage.
• Retirement (401k)
  • 100% company match up to the first 3% of employee contributions.
  • 70% match on contributions between 3% and 6%.
• Paid Time Off
  • Available for use after 90 days of employment.
  • Vacation & Floating Holidays: Frontloaded on January 1 annually based on tenure.
  • Sick Leave: Accrued in compliance with Massachusetts state regulations.
  • Company Holidays: 9 paid company holidays (8 hours each) + 24 hours of floating holidays per calendar year.
• Additional Perks
  • Employee Assistance Program (EAP) available immediately upon hire.