Bachelor's degree in life sciences, engineering, pharmacy, or related discipline; advanced degree preferred.
7+ years in GMP Quality Assurance, Quality Systems, or manufacturing quality in the pharmaceutical or biotechnology industry.
Hands-on experience with electronic Quality Systems, preferably Veeva Vault applications.
Experience managing Quality Events in an electronic Quality Management System, including Change Controls and CAPAs.
Strong understanding of quality system processes and regulatory inspection readiness.
Demonstrated technical writing skills for SOPs and controlled documents.
Strong organizational and analytical skills.
Responsibilities
Manage and maintain compliant electronic Quality Systems, including Document Management and CAPA.
Support Quality Events from initiation to closure, ensuring timely reviews and approvals.
Monitor workflows for Quality Events, identifying bottlenecks and facilitating improvements.
Draft and revise SOPs and controlled documents to align with GxP requirements.
Ensure harmonization across GxP domains and compliance with regulations.
Troubleshoot GxP system issues and support workflow improvements for various departments.
Administer the GxP training program and maintain inspection-ready training records.
Benefits
Medical, Vision, and Dental benefits starting the first of the month after hire.
Generous paid time off and designated company 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.
Recognized as a Great Place to Work® for eight consecutive years.
Full 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
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