AVP, Quality Systems & Compliance

Job Description Although one or more potential candidates for this position have been identified via internal succession planning, we will consider applications from any interested applicants. No relocation is provided for this role. The Position The Quality Compliance Lead reports directly to the Head of Quality. The role is responsible for the establishment, maintenance and continuous improvement of the global QMS (Quaity Management System) inclusive of OMS & R&D functions and Global GxP Compliance (cGMP, cGDP, cGVP, cGCP and cGLP).

The Quality Compliance Lead is responsible for oversight of GxP Audit & Compliance, Operational Quality Oversight of R&D functions, Quality oversight and maintenance of design for medical devices & combination products, the end to end (E2E) complaints management process for pharmaceutical and device products, microbiology, analytical standards management and QMS Operations.

Primary Responsibilities include, but are not limited to:

• Lead Development and Implementation of Quality Strategy and Planning on behalf of both OMS & R&D
• Report on significant quality issues to senior management
• Develop an annual risk-based audit plan for cGMP audits at all manufacturing sites and external partners, such as external manufacturers, business partners, intermediate & bulk suppliers, excipient and critical / primary component suppliers and other suppliers and service providers
• Develop an annual risk-based audit plan for cGVP audits of PV vendors, affiliates and internal functions to ensure compliance w/ cGVP regulations and expectations
• As operations dictate, execute cGCP / cGLP audits of vendors, study sites and internal functions in support of clinical activities
• Ensure implementation of the audit plan and timely completion of appropriate follow-up activities based on the outcome of the audit
• Direct the Quality Management System (QMS) program to assure ongoing compliance of site and functional QMS
• Maintain and/or change the QMS and any supportive documents / tools
• Ensure each chapter in the QMS has an assigned owner for each subordinate topic
• Ensure Topic Owners have sufficient resources to perform their responsibilities
• Assign a designee to approve global Quality related documents, including quality standards and global procedures
• Provide Quality Oversight for validation and qualification, IT & Quality risk management activities
• Champion Global Quality initiatives and other applicable operational unit or corporate strategic initiatives
• Provide global support for all manufacturing sites regarding product quality complaint processes, case management, trending and metrics
• GxP Quality Lead for R&D and member of the extended R&D Leadership Team

Main activities:

• Final approval of annual schedule of internal/external GxP quality audits
• Final approval of toxicology and medical assessment requests
• Aggregation of GxP risk management inputs & aligning action w/ Global Quality Strategy and Quality Planning
• Defining and monitoring key process and health indicators for action during quality governance
• Develop global quality strategy and quality plan
• Product Quality & R&D Quality inputs for Enterprise Risk Management
• Oversight of the Global Quality Compliance organization of ca. 80 staff

The Quality Compliance Lead is accountable for the following processes for which their direct reports are responsible:

• Updating global quality manual and ensuring the QMS meets the requirements to be compliant, effective and efficient and is appropriately BT enabled
• Writing global quality standards and procedures
• Conducting internal and external Site Quality Audits, including, but not limited to, the external API sites
• Approval of global quality standards
• Approval of global quality procedures
• Approval of…