Corporate Quality Regulatory Manager

Job Summary:

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:

• As the Corporate Quality Regulatory Manager, you will embrace a series of integral responsibilities that drive excellence in our quality practices, including but not limited to:
• 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.

Required Competencies:

• Regulatory Knowledge: Thorough understanding of food, drug, and quality regulations governing the manufacturing industry, including awareness of FDA and GMP guidelines.
• Analytical Thinking: Strong problem-solving abilities and the capacity to analyze complex regulations and quality systems to support decision-making processes.
• Communication Skills: Exceptional verbal and written communication skills, enabling effective collaboration across various teams and the promotion of compliance culture throughout the organization.
• Attention to Detail: High level of attention to detail in document control and regulatory submissions, ensuring accuracy and compliance with industry standards.
• Leadership: Proven leadership skills to guide a team towards achieving quality objectives and fostering a culture of accountability and continuous improvement.
• Project Management: Strong organizational skills with the ability to manage multiple projects and deadlines effectively.
• Adaptability: Flexibility to adapt to changing regulations and organizational needs, demonstrating resilience in a fast-paced environment.
• Interpersonal Skills: Ability to build strong relationships with stakeholders, promoting collaboration and a positive work environment.
• Technical Proficiency: Proficient in the use of databases, ERP systems, and software tools relevant to quality management, including familiarity with document control systems.

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.

Work Environment:

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.