The key role of the Work Stream Lead is to remediate and maintain the Supplier Quality Management and Oversight Program to ensure the quality and compliance with Company and regulatory requirements.
The candidate must lead the remediation activities of the Purchasing Controls work-stream. The main responsibilities will be focused on leading multiple SME’ in identifying gaps from current processes based on regulatory commitments and ensuring that sustainable solutions are implemented on a timely manner which could include institutionalizing structured governance to provide oversight to suppliers.
In addition, the role is responsible of the Purchasing Controls project charter deliverables, resource management, and the communication plan.
· Owner of the Purchasing Controls remediation execution and on-time completions of commitments.
· Communicate to Remediation PMO the status, progress, issues and escalation following established processes.
· Establish, manage and maintain Supplier Qualification and Audit Program.
· Manage all aspects of Supplier Performance Management.
· Review and approve the supplier audit schedule as needed.
· Review and approve documents including SOPs, FRMs, and CAPAs related to Supplier Qualification and remediation activities.
· Act as quality representative for approving Supplier Evaluation Reports and completing supplier assessments.
· Review and approve responses to Material Safety Risk Questionnaires (MSRQ) and BSE/TSE statements.
· Manage, prepare, negotiate and resolve issues with Supplier Quality/Technical Agreements. Work with suppliers to meet regulatory requirements, identification and inclusion of any mitigating responsibilities to ensure compliance.
· Work with Company Global Supply groups (center functions, other sites) as needed: Manufacturing & Supplier Quality Assessments (MSQA) Team, other Company site’s Supplier Compliance Groups, Procurement, etc.
· Assist with preparation and/or facilitation of regulatory inspections as needed.
· Bachelor/Master degree in Pharmaceutical Science, Laboratory Sciences, Engineering or equivalent and/or demonstrated equivalent experience with proven success.
· Previous Supervisor/Managerial Experience, required.
· Lead Auditor certification (CQA/ASQ/ISO) preferred / Prior auditing experience required.
· Understanding of Medical Device Safety Risk Management (ISO 14971, ISO 62304, IEC 60601-1:2005, etc.).
· Proficient interpreting FDA, EMA, MHRA, and Rest of World cGMP regulations for pharmaceuticals and/or device.
· Must have strong inter-personal skills, ability to manage projects, must learn quickly, must be intuitive, self-reliant, and possess excellent analytical and leadership skills.
· Minimum seven (7) years’ experience in the pharmaceutical and/or medical device manufacturing industry, required.
· Knowledge of Regulatory Compliance and Quality Systems, required.
· Excellent self-management, time management, and problem solving skills; must be able to multi-task / multi-project.
· Strong computer skills (e.g. Word, Excel, PowerPoint, SharePoint, Adobe Acrobat) and other data management tools.
· Critical skills needed include leadership, collaboration, attention to detail, demonstrated business and compliance acumen, project management, communication skills, and team performance management.
· Experience with preparation and/or facilitation of regulatory inspections (FDA, EMA, etc.) preferred.
· Must have the ability to simultaneously multi-task across multiple capabilities and functions and handle multiple competing priorities and requirements, including performing site and functional responsibilities, responding to frequent e-mail and phone communications and attending multiple meetings and conference calls. Note that these activities may not be time bound to core hours or presence at the site.
· Must have the ability to work effectively under and manage to strict production, time and performance deadlines.
· The ability to actively listen to others’ viewpoints as well as facilitating and positively contributing to group discussions.
· Excellent organizational skills, managing different communication channels and being able to clearly and concisely update colleagues on progress and milestones achieved.
· Capable of working well with others and effective at getting the input of everyone on the team including quieter members.
· Possesses the capacity to compromise and is willing to make concessions in order to move the group forward in finding solutions.
· Works to achieve innovative and sustainable solutions to support the manufacturing operations of the facilities.
· Travel between Brentwood and Westport locations required.