Senior Quality and Regulatory Specialist

Job Summary
The Quality & Regulatory Senior Specialist plays a critical role in supporting PakLab’s Quality and Regulatory organization through the oversight, maintenance, and continuous improvement of the PakLab Quality Management System (QMS). This role ensures that company operations, products, and documentation consistently meet internal quality standards, customer expectations, and all applicable regulatory requirements.The position is responsible for managing and supporting key quality and regulatory processes including, but not limited to, training program administration, internal and external audits, customer complaint investigations, validation and qualification activities, change control, deviation and CAPA management, regulatory documentation requests, label and artwork review, regulatory licensing and registrations, and formal regulatory correspondence.

The Sr. Specialist is expected to ensure that all quality records are complete, accurate, inspection-ready, and maintained in accordance with Good Manufacturing Practices (GMP) and company procedures. In this role, the individual will act as a subject matter expert for quality and regulatory compliance, providing guidance to cross-functional teams and helping ensure that business decisions appropriately consider regulatory and quality risk. The Sr. Specialist will work closely with Operations, Production, Regulatory Affairs, R&D, Supply Chain, and Commercial teams to proactively identify compliance risks, resolve quality issues, support product lifecycle activities, and implement effective corrective and preventive actions when required.

The position requires a hands-on, detail-oriented professional who can operate both tactically and strategically within the organization. Beyond routine QMS management, the Sr. Specialist is expected to actively contribute to process improvement initiatives, quality culture development, and operational excellence efforts. This includes supporting the development and monitoring of Key Performance Indicators (KPIs), trending quality data, identifying systemic issues, and recommending improvements to strengthen the overall effectiveness of the Quality Management System.

The Quality & Regulatory Sr. Specialist is also expected to maintain a high level of inspection readiness, supporting regulatory inspections, customer audits, and internal assessments. The role requires strong organizational, analytical, and communication skills, as well as the ability to clearly articulate regulatory expectations and quality requirements to stakeholders across the organization.Ultimately, this position plays an important role in ensuring that PakLab maintains a robust, compliant, and continuously improving quality system, while supporting the organization’s commitment to product safety, regulatory compliance, and customer satisfaction.

Essential Duties and Responsibilities

• Maintain and manage overall QMS processes and documentation.
• Manage the internal audit program by preparing schedules, conducting audits, and documenting findings.
• Manage and host the external audit program including preparation, staging, hosting, and corresponding.
• Support and oversee supplier qualification, monitoring, and audits.
• Review customer complaint reports, audit response reports, and change control reports for accuracy and compliance.
• Manage and support investigations of non-conformances, customer complaints, and product quality issues.
• Manage and support CAPA (Corrective and Preventive Actions) development, implementation, and verification.
• Track and report quality metrics and performance trends to management.
• Participate in training and onboarding of employees on GMP, quality procedures, and compliance requirements.
• Manage and oversee document control system and training compliance.
• Ensure compliance with applicable GMP, FDA, ISO for drugs and cosmetics as well as customer-specific requirements.
• Oversee and support preparation for customer and regulatory audits, including FDA and ISO.
• Identify opportunities for process improvements and contribute to continuous improvement initiatives.
• Perform other duties as assigned.

Required Skills and Abilities

• Strong knowledge of FDA drug and cosmetic requirements, ISO 22716, CGMP, quality systems, and regulatory compliance requirements.
• Excellent organizational, recordkeeping, and documentation control skills.
• Strong analytical and problem-solving skills with attention to detail.
• Effective communication and collaboration skills across departments.
• Proficiency in Microsoft Office Suite and hands on experience with quality management systems (QMS).
• Ability to manage multiple priorities and deadlines in a fast-paced environment.
• Self-starter, out of box thinker, and a change agent advocate .

Education and Experience Requirements

• Bachelor’s degree in Quality, Life Sciences, Engineering, or related field preferred.
• 5-7 years of hands on regulatory compliance , quality assurance, and quality systems experience in a high volume manufacturing environment.
• Experience in cosmetics, pharmaceuticals, or consumer packaged goods required.
• Experience supporting audits and compliance programs required.

Physical Demands and Working Conditions

• Prolonged periods of sitting at a desk and working on a computer.
• Frequent walking and standing on the production floor.
• Ability to lift up to 25 pounds occasionally.
• Onsite working hours in core business hours.
• Work performed in both office and manufacturing environments.
• Exposure to noise, machinery, chemicals, and production materials when on the production floor.
• Flexibility to work extended hours, weekends, or shifts to meet business needs and audit schedules.

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities required of the employee. Duties, responsibilities, and activities may change at any time, with or without notice.

Equal Employment Opportunity (EEO) Statement

Universal Packaging Systems, Inc. DBA PakLab is an Equal Opportunity Employer. We do not discriminate based on race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), sexual orientation, gender identity, gender expression, national origin, ancestry, age, physical or mental disability, medical condition, genetic information, marital status, military or veteran status, or any other characteristic protected by applicable federal, state, or local law.

Pay: $95,000.00 - $110,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Health savings account
• Vision insurance

Work Location: In person