Quality Compliance Manager

This role is responsible for leading the Veranova Quality Systems & Compliance team. This role will oversee the compliance function and related processes for the multi-site New England region. The position manages and provides direction to Quality Systems and Compliance staff, ensuring that processes and activities are performed in compliance with company policies, procedures, standards and applicable local, state, federal, and international regulations relating to the manufacture of active pharmaceuticals (APIs) and intermediates. This role will partner with various internal and external cross-functional teams as well as external regulatory and auditing agencies. 

Core Responsibilities: 

• Oversees the management of the Quality Systems & Compliance team supporting complaints, Annual Product Quality review, internal audit program, inspection readiness, Quality metrics, change management, quality events, supplier quality, environmental monitoring and Quality Management Review (QMR).
• Process owner for Quality Systems Management processes including Quality Events, quality metrics, change management, complaints, and document control. Lead or actively participate in implementation of updates and enhancements to these processes.
• Provide project and Subject Matter Expert support for all activities involving modifications, upgrades and or business process changes related to Quality Systems tools and applications.
• Develop and implement ways to improve Quality Systems business processes and strategies, which increase efficiency, improve compliance, and reduce system maintenance requirements.
• Partner with the IT organization to manage initiatives related to Quality Management Systems.
• Responsible for inspection readiness and manage regulatory inspection processes relating to cGMP including, but not limited to, FDA, MHRA, EMA, Health Canada, and Notified Body, across multiple sites. May act as key liaison for local, state, federal, and global regulatory agency inspections.
• Participate and coordinate FDA inspections, audits, and inspections by other regulatory agencies. Lead customer quality audits, including audit responses and share voice of customer with extended compliance systems peers from other sites.
• Develops and manages the internal auditing program to ensure a constant state of compliance. Plans and executes compliance audits of internal operations as they relate to GxPs to ensure compliance with policies, procedures, and regulatory requirements; drives timely completion of associated corrective actions. Track and trend multi-site compliance issues to assure alignment with corporate standards.
• Respond in a timely manner to compliance concerns and contribute to problem resolution.
• Manages the creation and maintenance of compliance metrics, development of trend data of audit / inspection observations and quality events, and communication of results expediently to applicable groups.
• Identify areas of improvement and participate in process improvement initiatives. Implements quality and process improvements evaluating multiple perspectives. Create new processes aimed at continual improvements, supporting a LEAN company culture. 
• Aid in the harmonization and maintenance of harmonization of the Quality Management Systems across sites, updating procedures, decision trees and compliance tools for the site, as needed.
• Responsible for driving functional excellence though the tactical execution of improvement activities.
• Manages the range of performance management processes for direct reports.
• Other duties as assigned.

Qualifications: 

Required

• Minimum 11 years of quality assurance and quality systems experience with an undergraduate degree in engineering, science or related field
• Minimum 9 years of quality assurance and quality systems experience with an graduate degree in engineering, science or related field
• Proven leadership experience in pharmaceutical, API/intermediate, medical device, biologics or related FDA industry
• Demonstrated proficiency and knowledge of cGMP, ICH, and other US and worldwide regulatory requirements
• Working knowledge of US & EU GMP, ICH Q7 and Part 11 compliance
• Have previous experience auditing for cGMP compliance
• Experience with project management and gap assessment projects 
• Experience creating metrics for driving continuous improvement
• Experience driving complex projects with the ability to initiate, prioritize, and successfully complete tasks
• Proven experience working effectively in team situations and as an individual contributor
• Demonstrated behavior that models the Veranova culture to achieve an inclusive environment and exceptional business results
• Excellent communication and interpersonal skills with the ability to lead, manage and develop cross-functional relationships.
• Analytical mindset with a strong attention to detail and problem-solving skills
• Demonstrated excellent verbal and written communication skills
• Demonstrated networking and influencing skills; ability to collaborate and influence effectively across a broad range of associates spanning varied disciplines and responsibilities
• Previous people management and/or team leadership experience 

Preferred

• Certified Lead Auditor certificate, or certification(s) in Lean manufacturing methods/tools such as structured problem solving, Lean Six Sigma, etc. desired

Our Commitment:

• Health & Wellness: Comprehensive health & Wellness benefits. Access to mental health resources and wellness programs. Generous PTO and holiday pay policies. 
• Financial Wellness: Comprehensive total compensation package that includes competitive base salary, Defined Contribution Pension program, eligibility for performance-based bonuses, and attractive 401(k) Plan with company match.
• Professional Development: Opportunities for continuous learning through LinkedIn Learning, workshops, conferences, and mentorship. Tuition Assistance for Undergraduate and Graduate degree programs.
• Inclusive Culture: At Veranova an inclusive culture is integral to our values. We are committed to ensuring that everyone can bring their full self to work and thrive in their career.