Manager, Quality Partners

Job Title

Requisition

Location

Additional Locations

Job Description Summary

Job Description

The Manager, Quality Partners, is responsible for ensuring that quality and compliance standards are consistently met for product supply across both international and domestic markets. This is achieved through close collaboration with Global Operations, Engineering, Quality, Regulatory, and Commercial teams. The role plays a critical part in supporting the development and delivery of high-quality, compliant products and services, with a focus on Global Regional Service Centers (RSCs) and Wholesalers.

This position requires strong analytical and technical decision-making skills. Internal stakeholders will depend on the individual to make timely, data-driven decisions and to provide the necessary guidance and support to implement them effectively. The role also champions a culture of continuous improvement and cross-functional collaboration throughout the organization.

• Develop and execute strategic quality improvement plans in collaboration with key stakeholders

• Ensure RSCs maintain inspection readiness and comply with global regulatory standards (e.g., MDSAP, ISO 13485, FDA, EU MDR)

• Analyze quality data to identify trends, track progress, and assess improvement initiatives

• Lead investigations and root cause analysis for quality issues, implementing sustainable corrective actions

• Support internal/external audits and regulatory inspections, ensuring consistent compliance

• Design and deliver quality training programs to promote regulatory understanding and operational excellence

• Standardize and update quality processes and systems across RSCs and related functions

• Serve as quality liaison with pharmaceutical wholesalers and collaborate with Trade, Market, and Logistics teams

• Provide coaching to non-quality staff and maintain strong cross-functional relationships

• Contribute to regional strategic planning, special projects, and change control initiatives across quality, supply chain, and engineering functions

• Bachelor's degree in Engineering, Science, or a related field

• 7+ years of experience in the medical device and pharmaceutical industry

• Strong knowledge and in-depth understanding of GMP/GDP requirements, particularly in the US, Canada, and Australia

• Hands-on experience with quality systems including CAPA, deviations, root cause analysis, change control, and compliance in distribution/commercial settings

• Demonstrated success in auditing, regulatory inspections, and issue impact assessments

• Skilled in leading root cause investigations and corrective actions in regulated environments

• Proficient in document management systems and quality management tools

• Proven ability to lead cross-functional initiatives and drive change through strong collaboration, influence, and relationship-building

• Effective communicator with strengths in presenting complex ideas, facilitating teamwork, and aligning diverse stakeholders

• Skilled in problem-solving and decision-making, with the ability to manage multiple priorities independently while fostering cross-departmental partnerships

Frequent communication and working relationships with distribution sites and distribution centers, and different functions within and outside the company (quality, operations, supply chain).

Normal office conditions

Travel required (25 - 40%) - both domestic and international

The expected base pay range for this position is $95k - $135k. Please note that base pay offered may vary depending on factors including job-related knowledge, skills, and experience. This position is eligible for a bonus in accordance with the terms of the applicable program. Bonuses are awarded at the Company's discretion. Mallinckrodt Pharmaceuticals offers employees a Total Rewards package which includes competitive pay and benefits. To learn more about our Total Rewards benefits please visit:Benefits & Well-Being

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