AMICUS THERAPEUTICS IS A GLOBAL, PATIENT-DEDICATED BIOTECHNOLOGY COMPANY FOCUSED ON DISCOVERING, DEVELOPING, AND DELIVERING HIGH-QUALITY MEDICINES FOR PEOPLE LIVING WITH RARE METABOLIC DISEASES.

The Quality Lead, Quality Compliance and Operational Excellence will oversee the Global Process for Product Complaints for Marketed Products and Clinical Trails and will also assist to drive organizational performance through workforce empowerment using collaboration, proven lean six-sigma tools, and change management methodologies.
This role will emphasize compliance with SOPs and applicable regulations. They will interact with key stakeholders in the organization for timely and accurate receipt of complaint reports. This role will lead/facilitate complaint investigations, report complaint trends and escalate issues to Management. They will lead the training of Amicus personnel for the responsibilities and requirements for the identification and handling of complaints. This role will also interact with Health Authority inspectors as the Global Complaints Process Lead/SME.
They will assist with supporting and developing a Quality Compliance and Continuous Improvement culture ensuring that Global Quality Operations are carried out in a compliant and efficient manner including leading and/or facilitating internal audits.
They will compile and author Annual Product Quality Review (APQR) global summary reports for all commercial products.

EDUCATIONAL REQUIREMENTS

• 
  
  
  
• BA, BSc in a relevant field, such as Engineering, Sciences or similar.

• Certification in lean Six Sigma (Green Belt or higher) or similar.

PROFESSIONAL WORK EXPERIENCE REQUIREMENTS

• 
  
  
  
• Experience in a GMP manufacturing environment.

• 0Minimum 10 years experience in GxP or similar regulated environment.
• Strong working knowledge of global regulatory and GxP requirements.
• At least 5 years of experience in QA, compliance, complaints management, continuous improvement, operational excellence, or related field in the pharmaceutical industry.
• Strong analytical skills and experience using lean Six Sigma, or similar tools and techniques.
• Ability to work in a Global Environment.
• Excellent communication and interpersonal skills, with the ability to build relationships and work effectively with stakeholders at all levels of the organization.
• Strong project management skills, with the ability to manage multiple projects simultaneously and deliver results on time and on budget.
• Experience of management of external partners and contract manufacturing.
• Experience in working with global third party service providers and international call centers.
• Experience in quality metrics reporting and analysis as well as process improvement techniques. Experience in reporting Complaints trends.
• Excellent organizational, analytical, strategic, interpersonal, written and oral skills required.
• Self-motivated and flexible with the ability to work effectively in a dynamic, problem-solving environment is required.
• Proficient with computer usage and applications such as Microsoft Word, Powerpoint and Excel.
• Experience performing and supporting internal audits and Health Authority inspections

EXPERIENCE AND SKILLS

• 
  
  
  
• Able to act operationally, tactically, and strategically, to implement Compliance and Operational Excellence and Continuous Improvement programs.

• Ability to influence Global stakeholders and internal and external subject matter experts.
• Excellent analytical and critical thinking, demonstrating ability to analyse and solve problems.
• Autonomy, self-motivation and efficiency, with an appropriate sense of urgency in a fast-paced and dynamic environment.
• Knowledge of Pharmaceutical Drug Substance, Drug Product, and Packaging Manufacturing operations.
• Strong verbal and written skills with ability to explain complex, challenging topics clearly and persuasively at all levels of the organisation.
• Able to act operationally, tactically, and strategically, to implement Compliance and Operational Excellence and Continuous Improvement programs.
• Ability to influence Global stakeholders and internal and external subject matter experts.
• Excellent analytical and critical thinking, demonstrating ability to analyse and solve problems.
• Autonomy, self-motivation and efficiency, with an appropriate sense of urgency in a fast-paced and dynamic environment.
• Knowledge of Pharmaceutical Drug Substance, Drug Product, and Packaging Manufacturing operations.
• Strong verbal and written skills with ability to explain complex, challenging topics clearly and persuasively at all levels of the organisation.

OTHER SKILLS/ATTRIBUTES

• 
  
  
  
• Demonstrated alignment with Amicus Mission Focus Behaviors

• Passion for rare disease and patient focus

• 
  
  
  
• Ensuring the Quality Management systems are aligned to and operate in compliance with applicable quality standards and global regulatory requirements as well as supporting the development of an effective and mature Quality Culture.

• Ensuring the aforementioned systems are operated in an efficient and effective manner and identifying and actioning opportunities for improvement. This includes performing and/or facilitating internal audits of systems.
• Support the development and implementation of a program to drive continuous improvement and operational excellence across the organization.
• Work closely with key stakeholders across Supply Chain, Finance, Quality, Technical Operations and Regulatory to identify opportunities for improvement, prioritize projects, and develop and implement solutions.
• Use the principles and tools of lean Six Sigma to analyse processes, identify root causes, and develop and implement solutions.
• Work cross functionally to ensure that continuous improvement initiatives are aligned with the overall goals and objectives of the organization.
• Measure and report on the effectiveness of continuous improvement initiatives, including the impact on key performance indicators such as cost, quality, and customer satisfaction.
• Provide subject matter expert advice & coaching.
• Actively seek opportunities for improvement and feedback from users and stakeholders.
• Manage relationships with key stakeholders and users.
• Facilitate the sharing and adoption of best practices across Amicus.
• Review and approve all complaint investigations for clinical trials and commercial products ensuring all complaints are thoroughly investigated and CAPAs are implemented as needed. Ensures timely review, thorough root cause analysis, adherence to SOPs and escalations of critical issues to Management.
• Support processing and monitoring of formal escalations to Management as per Amicus SOPs as required.
• Ensures procedures are established and followed to identify if a complaint is reportable under applicable regulations and documents the decision process. Evaluates all complaints for criticality, reporting requirements and adverse trends.
• Conducts complaint training for internal and external departments.
• Participate in audits as necessary (internal/external) as the SME/Global Process Owner of Complaints Process.
• Support cross functional team with PV, GCP and GMP/GDP on Complaint investigations. Lead the periodic Compliant Review Board team meeting. Ensuring records are progressing to closure and escalate as needed.
• Prepare, Trend and present Complaint metrics at various Management Review forums for the organization (Quality Council, QMRs etc.).
• Lead and support Trackwise changes and upgrades related to the Complaints module. Support as needed Trackwise team with execution of UATs, revisions/creation of SOPs, Guidance Documents and Training.
• Lead and support Mock Inspections and Health Authority inspections (PAI and periodic GXP/PV audits) as the SME for Complaints and support inspection processes (Back Room, QC Check, Scribe, etc) as needed.
• Lead and support Quality Management Systems process improvement/projects for Complaints and other QMS processes as needed (Quality Events, CAPA and Supplier Quality and Audits).
• Support QMS processes as needed based on workload.
• Lead and support Quality Progression Plans/projects as needed.
• Compile and author annual product quality review (APQR) summary reports for Amicus commercial products as per Amicus SOP engaging with internal and external stakeholders to ensure compliance and on time approvals.
• Support global QRM processes and reporting ensuring alignment with Amicus QMS requirements.
• Assist with monitoring global regulatory updates (FDA, EMA, ICH etc.) and associated gap assessments with SMEs to assess their impact on the QMS and current operations. Assist with reporting of gap assessments and associated CAPA at management review forums.