Corporate Quality Regulatory Manager

Pretium Packaging; St. Louis (MO); On-site; USD 60,000 - 100,000; Full time

Job summary

This innovative firm is seeking a Corporate Quality Regulatory Manager to enhance quality standards across all sites. You will lead regulatory compliance, oversee quality management systems, and ensure that products meet industry standards. Collaborating with a diverse team, you will drive continuous improvement and support customer audits while staying ahead of regulatory changes from bodies like the FDA and EU. If you thrive in dynamic environments and are passionate about quality, this role offers a unique opportunity to make a significant impact on corporate success and compliance culture.

Qualifications

• Bachelor's degree or equivalent experience required.
• Minimum 1 year in a Regulatory/Compliance role preferred.

Responsibilities

• Lead regulatory compliance and communication for products and materials.
• Develop and manage quality management system documents.
• Support sales with regulatory requirements and audits.

Skills

Regulatory Compliance

Quality Management

Mathematical Reasoning

Organizational Skills

Decision Making

Adaptability

Education

Bachelor’s degree

Tools

Database Systems

ERP Systems

Job description

Are you passionate about quality and regulatory compliance in the manufacturing sector? Pretium Packaging is seeking a dynamic Corporate Quality Regulatory Manager to join our team! In this role, you will be at the forefront of supporting our corporate quality standards across all Pretium sites. You will lead the regulatory compliance and communication activities pertaining to finished products and raw materials, which includes preparing and submitting regulatory applications, ensuring correct interpretation of regulatory information, and providing regulatory information to customers and internal stakeholders. Additionally, you will spearhead the development and oversight of our quality management system documents, ensuring that our policies and procedures not only meet but exceed industry standards. Collaborate closely with our Senior Director of Quality and a diverse team to enhance our processes, support customer audits, and foster a culture of continuous improvement. If you thrive in fast-paced environments and are driven by a commitment to quality, this opportunity is for you!

Key Responsibilities:

• Lead the preparation and submission of all regulatory agency applications, reports, and communications.
• Act as a regulatory authority for various departments ensuring all product development and marketing efforts align with compliance standards.
• Ensure the accurate communication of regulatory information across multiple departments.
• Create and maintain a robust regulatory library, encompassing Drug Master Files and essential regulatory testing documentation.
• Support the sales team in understanding regulatory requirements to drive business opportunities.
• Prepare and publish timely regulatory position statements on behalf of Pretium Packaging.
• Develop and enforce regulatory rules and procedures in compliance with GMP and certification policies.
• Provide accurate regulatory information to customers and assist with their quality specifications during onboarding.
• Review and approve Quality Agreements, ensuring communication of implications to sales and quality teams.
• Inform the commercial team of raw material regulations, assisting with Change Notifications as necessary.
• Collaborate with marketing for product rationalization and updates to catalogs.
• Stay ahead of industry regulatory changes and assess their impact on Pretium, integrating insights from FDA, EU, Canadian FDA, and other bodies.
• Manage document control for corporate SOPs and work instructions, ensuring timely updates and compliance.
• Offer external audit support to Quality Managers/Supervisors during 3rd party audits.
• Assist in managing plant HACCP programs and CCPs lists.
• Oversee the Corporate Quality training library and logs.
• Stay knowledgeable about FDA requirements (21 CFR) concerning food/drug safety.
• Enhance professional growth by actively participating in relevant training, networking, and professional organizations.
• Elevate our department’s reputation by accepting new challenges and identifying opportunities for value addition.
• Exercise supervisory responsibilities in alignment with company policies and legal regulations.

Requirements:

• Bachelor’s degree from an accredited institution or equivalent experience.
• Minimum of one (1) year in a Regulatory/Compliance role; supervisory experience preferred.
• Quality certification (CQE, CQA, ASQ, etc.) is a bonus but not mandatory.
• Previous experience in industry-specific environments is advantageous.
• Strong mathematical and scientific reasoning aptitude, proficient in concepts such as probability and statistical inference.
• Proficient in IT and computer applications, supporting diverse Database and ERP systems with a solid understanding of database structures.
• Exceptional organizational and decision-making abilities.
• Flexible and adaptable to changing work schedules.

Safety and Housekeeping:

Adhere to all required PPE protocols. Follow established procedures to maintain a safe and organized work environment.

Physical Demands:

This role requires a balance of sitting, standing, walking, lifting, and computer-based tasks. The ability to communicate effectively and respond to auditory signals is essential.

Our work environment typifies a classic office atmosphere, with occasional requirements to be present on the manufacturing floor where noise levels may be elevated. Safety gear will be provided and worn as the environment dictates.

Join Us! If you are ready to advance your career in a challenging and rewarding role that impacts corporate success and fosters a culture of quality compliance, we invite you to apply for the Corporate Quality Regulatory Manager position at Pretium Packaging!

Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Quality Assurance

Industries

Packaging and Containers Manufacturing