Primary Role:

The Quality Systems Manager at Myonex is responsible for overseeing Myonex’s Pharmaceutical Quality System to ensure compliance with GMDP requirements. This role leads quality systems, audit programs, vendor qualification, and training, while managing the Quality Systems team and collaborating cross-functionally with Production Quality and Operational teams.

This role is hybrid (3 days a week onsite) at our Headquarters in Horsham, PA with working days of Monday - Friday at 8AM - 4:30PM.

Duties:

• Maintain and continuously improve the Pharmaceutical Quality System, including change control, deviations, CAPA, complaints, recalls, document control, training, risk management, vendor qualification, equipment/facility maintenance, calibration, and quality management review.
• Monitor quality system activities (e.g., change controls, deviations, investigations, CAPAs) to ensure timely progression, effective resolution, and proper closure.
• Lead investigations related to deviations, OOS results, and complaints, ensuring appropriate root cause analysis and corrective/preventive actions.
• Author, review, and approve Standard Operating Procedures (SOPs), technical agreements, and other controlled documents.
• Archive quality documents accurately within electronic and physical document management systems.
• Manage internal and external audit programs, including self-inspections, supplier audits, and customer audits; host audits and support regulatory inspections as needed.
• Participate in supplier qualification and ongoing monitoring, including risk assessments, approvals, and periodic re-evaluations.
• Coordinate and maintain training programs, including training needs analysis, development of training plans, and ensuring completion of GMDP and role-specific training.
• Drive quality culture and ensure compliance with cGMP, FDA, ICH, and other applicable regulatory requirements.
• Lead risk management activities, including identification, evaluation, and mitigation of risks.
• Organize and lead Quality Management Review meetings, including development and presentation of quality metrics.
• Maintain and manage technical agreements with suppliers and service providers.
• Manage, mentor, and develop Quality Systems team, including onboarding, training, performance management, and workload planning.
• Escalate significant quality, compliance, or operational risks to the Associate Director, Quality, or senior management, as appropriate.
• Perform additional GMDP-related duties as assigned by the Associate Director, Quality.
• Embody the Myonex Core Values: Be a Great Team Player; Be Client Focused; Learn & Grow; Find a Way

Education & Experience:

• Bachelor’s degree in science or related field with 3 to 6 years of related experience in pharmaceutical quality assurance or a combination of FDA regulated environment in quality/regulatory fields.
• 7 or more years of relevant experience in an FDA regulated environment in lieu of education is acceptable.
• 1-2 years’ experience in auditing.
• Working knowledge of cGMP principles with respect to appropriate regulatory requirements (FDA, ICH guidelines).

Skills & Qualifications:

• Strong decision-making, analytical, and problem-solving skills with the ability to evaluate complex situations and drive effective outcomes.
• Demonstrated ability to plan, prioritize, and manage multiple projects and responsibilities simultaneously while meeting deadlines and adapting to changing priorities.
• Excellent organizational skills with a high level of accuracy and attention to detail.
• Solid understanding of GMP, GDP, and other applicable regulatory requirements; general knowledge of EU regulatory requirements preferred.
• Strong written and verbal communication skills, including report writing and the creation and revision of technical and quality documentation.
• Effective interpersonal skills with the ability to coach, guide, and influence stakeholders at all levels of the organization.
• Results-oriented, self-motivated, and driven, with the ability to work independently with minimal supervision.
• Ability to identify procedural gaps and proactively drive continuous quality and compliance improvements.
• Proficient computer skills, including Microsoft Office applications, email systems, and inventory management software.

Myonex is committed to ensuring equal opportunity in all aspects of employment. We do not discriminate against anyone on the basis of race, religion/creed, color, gender identity, sexual orientation, marital status, pregnancy, national origin, ancestry, military status, disability or perceived disability, use of a guide or disability support animal, or membership in any other protected class as defined by applicable laws and regulations. If an employee or applicant feels they have not received equal or fair treatment, we encourage them to contact Human Resources.