Senior Manager, Quality Systems

Harmony Biosciences; Harmonville (PA); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Medical, Vision & Dental

Paid time off

Disability & Life Insurance

401(k) Plan

Parental leave

ESPP

Wellness programs

Professional development

Great Place to Work

Job summary

Harmony Biosciences is seeking a Senior Manager, Quality Systems to support GxP quality systems in the Plymouth Meeting office. You will administer Quality Events, document control, training processes, SOP revisions, and Quality metrics to ensure inspection-ready systems and continuous improvement across GMP/GLP/GCP domains.

The role requires hands-on experience with electronic quality systems (preferably Veeva Vault), change controls, deviations, CAPAs, and training management, plus strong

Qualifications

• Bachelor's degree in life sciences, engineering, pharmacy, or related discipline
• 7+ years GMP Quality Assurance, Quality Systems, or manufacturing quality in pharmaceutical/biotech
• Hands-on experience administering or supporting electronic Quality Systems (preferably Veeva Vault QualityDocs/Training/eQMS)
• Experience initiating, reviewing, and managing Quality Events (Change Controls, Deviations, CAPAs, CI records)
• Strong understanding of quality system processes: document control, training, deviations, CAPA, change control, risk management, investigations, inspection readiness
• Technical writing and document management skills with SOPs, work instructions, forms
• Strong computer, organizational, and analytical abilities
• Excellent verbal and written communication across stakeholders

Responsibilities

• Maintain electronic Quality Systems (Document Management, Training, Change Control, Deviations, CAPA)
• Provide day-to-day support for Quality Events from initiation through closure
• Monitor Quality Event workflows, aging, and due dates; escalate bottlenecks and improve processes
• Draft, revise, and review SOPs, work instructions, forms, and controlled documents
• Ensure harmonization across GMP/GLP/GCP and regulatory standards
• Troubleshoot Veeva Vault and other GxP systems; coordinate issue resolution and user support
• Administer GxP training program and related processes (Veeva Vault Training, curricula)
• Ensure systems meet regulatory requirements and business needs
• Oversee document lifecycle activities in Veeva Vault QualityDocs
• Develop Quality System metrics and trends; prepare Quality Management Review materials
• Collaborate with process owners to ensure procedural compliance and proper eQMS use
• Provide oversight for additional GxP-regulated systems; perform other duties as assigned

Education

Bachelor's degree in life sciences, engineering, pharmacy, or related discipline

7+ years GMP Quality Assurance/Quality Systems experience

Experience administering electronic Quality Systems (Veeva Vault)

Quality events management (Change Controls, Deviations, CAPAs)

Strong written and verbal communication

Tools

Veeva Vault QualityDocs

Veeva Vault Training

eQMS modules

Job description

Harmony Biosciences is recruiting for a Senior Manager, Quality Systems in our Plymouth Meeting office. In this role, you will provide day-to-day operational support for GxP Quality Systems in accordance with applicable ICH and FDA regulations and guidelines. The role is responsible for the daily administration and maintenance of Quality Events, controlled documents, training processes, workflows, SOP revisions, and Quality metrics to support compliant and inspection‑ready Quality Systems. The position works directly with process owners and business functions to maintain accurate records, troubleshoot system and workflow issues, monitor assigned activities, facilitate timely completion and escalation, and support consistent execution and continuous improvement of established Quality processes.

Responsibilities include but are not limited to:

• Manage and maintain a compliant state of the electronic Quality Systems, including but not limited to Document Management, Training, Change Control, Deviations, and CAPA.
• Provide day‑to‑day support for Quality Events, including Change Controls, Deviations, CAPAs, and Continuous Improvement records, from initiation through review, approval, implementation, and closure.
• Monitor Quality Event workflows, record quality, aging, and due dates; identify bottlenecks, facilitate timely escalation, and support sustainable process improvements.
• Draft, revise, route, and periodically review SOPs, work instructions, forms, and other controlled documents to maintain alignment with current processes and applicable GxP requirements.
• Ensure harmonization across GxP domains (GMP/GLP/GCP) and alignment with applicable regulations/standards.
• Provide operational support to Technical Operations, Regulatory Affairs, Clinical Operations, and Medical Affairs by troubleshooting Veeva Vault and other GxP system issues, coordinating issue resolution, assisting users, and supporting approved workflow improvements.
• Administer the GxP training program and related Quality processes, including Veeva Vault Training, role‑based curricula, training assignments, periodic review activities, and maintenance of inspection‑ready training records.
• Ensure that systems and business processes meet organizational business needs and regulatory requirements.
• Provide day‑to‑day administration and user support for document lifecycle activities within Veeva Vault QualityDocs, including document creation, review and approval workflows, periodic reviews, and archival activities.
• Develop, compile, analyze, and maintain Quality System metrics and trends, including cycle times, overdue items, training compliance, audit outcomes, CAPA effectiveness results, and open improvement actions; prepare and present assigned materials for Quality Management Review to support performance monitoring, risk escalation, and continuous improvement.
• Partner with process owners and cross‑functional stakeholders to clarify Quality System requirements, resolve workflow issues, reinforce procedural compliance, and promote consistent use of the eQMS.
• Provide oversight and support for additional GxP‑regulated systems, as needed. Perform other duties as assigned.

Qualifications:

• Bachelor's degree in life sciences, engineering, pharmacy, or a related discipline required; advanced degree preferred
• 7+ years within GMP Quality Assurance, Quality Systems, technical operations quality, or manufacturing quality required specifically within the pharmaceutical or biotechnology industry
• Demonstrated hands‑on experience administering or supporting electronic Quality Systems required, preferably Veeva Vault applications such as QualityDocs, Training, and eQMS modules
• Hands‑on experience initiating, reviewing, managing Quality Events in an electronic Quality Management System, including Change Controls, Deviations, CAPAs, and Continuous Improvement records.

• Strong understanding of quality system processes, including document control, training management, deviations, CAPA, change control, quality risk management, investigations, and regulatory inspection readiness.

• Demonstrated technical writing and document‑management skills, with experience authoring or revising SOPs, work instructions, forms, and controlled Quality System documents.

• Strong computer, organizational, and analytical skills required
• Strong verbal and written communication skills with the ability to communicate to colleagues, business partners, stakeholders and upper management across varied styles and cultures

Physical demands and work environment:

• Both global and domestic travel is estimated to be up to 15% of the time for this position; the candidate must be able to maintain or obtain a valid U.S. passport within 90 days of the hire date.
• While performing the duties of this job, the noise level in the work environment is usually quiet.
• The employee must occasionally lift and /or move more than 20 pounds.
• Specific vision abilities required by this job include: Close vision.
• Manual dexterity required to use computers, tablets, and cell phone.
• Continuous sitting for prolonged periods.

What can Harmony offer you?

• Medical, Vision and Dental benefits the first of the month following start date
• Generous paid time off and Company designated Holidays
• Company paid Disability benefits and Life Insurance coverage
• 401(k) Retirement Savings Plan
• Paid Parental leave
• Employee Stock Purchase Plan (ESPP)
• Company sponsored wellness programs
• Professional development initiatives and continuous learning opportunities
• A certified Great Place to Work for eight consecutive years based on our positive, values‑based company culture

Harmony Biosciences is a pharmaceutical company headquartered in Plymouth Meeting, PA. The company was established in October 2017 with a vision to provide novel treatment options for people living with rare, neurological disorders who have unmet medical needs. For more information on Harmony Biosciences, visit www.harmonybiosciences.com

Harmony Biosciences is an Equal Opportunity, e-Verify Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

Recruitment agencies please note:

Harmony Biosciences will only accept applications from agencies/business partners that have been invited to work on a specific role. Candidate Resumes/CV's submitted without permission or directly to Hiring Managers will be considered unsolicited and no fee will be payable. Thank you for your cooperation.

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