Job Information
Amicus Therapeutics Senior Director, Global Quality Management Systems in Marlow, United States
Senior Director, Global Quality Management Systems
Location Marlow, UK
Requisition ID 2276
# of openings 1
Apply Now (https://phh.tbe.taleo.net/phh04/ats/careers/v2/applyRequisition?org=AMICUS&cws=37&rid=1322)
Job Brief
Senior Director - Global Quality Management Systems
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.
Position Summary The Senior Director, Global Quality Management Systems, will be responsible for leading the Global Quality Management Systems team with responsibility for the Quality Management Systems (QMS). The primary role of this position will be to develop, implement, and continuously improve through risk-based processes the Amicus Quality Management Systems and associated systems and procedures. The role will work to collaborate with key stakeholders to provide systems for day-to-day GxP operations related to Quality Events, Investigations, CAPA, Change Management, Training, Document Management & Archival, Supplier Quality and Internal & External Audit Programs across the organization. This role will interact with key stakeholders (US and International) in the organization and support QMS activities for inspection readiness, KPIs/metrics, and QMS system validations. The Senior Director, Global Quality Management Systems will work collaboratively with all parts of the business to ensure compliance with global quality and regulatory requirements and drive a culture of quality throughout the company.
Roles and Responsibilities:
Quality Management System (QMS)
Create and/or maintain effective, value adding QMS applications, procedures, and processes that meet relevant global regulations
Ensure the effectiveness of the Quality System through regular reviews, audits, and updates.
Lead, coordinate, or support eQMS/eDMS enhancements or releases of systems (TrackWise, Master Control, Veeva) or implementation of new eQMS/eDMS. This includes system requirement setting, execution of UATs, updating required SOPS and creation/updates to Training materials. Training the business on changes related to implementation of changes and new systems.
Lead and direct programs for document management, GXP training, Quality Events/ CAPA, and change management.
Drive the change management program and implement efficient processes for the notification, assessment and implementation of changes to support program timelines.
Lead, manage, or support the implementation of new eDMS/LMS systems understanding the architecture for a global system to support GxP and Non-GxP training (i.e., curriculums, job codes, course implementation etc.)
Lead the trending and metrics programs for Quality related metrics, assess each functional area for trends and opportunities for improvement.
Conduct needs analysis for GxP training across the organization and identify or perform training using various platforms for global outreach.
Provide oversight of GxP training curriculums.
Lead and support eDMS for processing, periodic review and board meetings as needed.
Global GxP Compliance
Ensure compliance with global GxP Quality System requirements (FDA/EMA) with focus on EU and UK requirements as they apply to GDP and PV regulations.
Partner with commercial and affiliate teams to ensure robust systems are implemented and maintained to meet regulatory requirements.
Lead the teams for Management Review/Quality Council forums associated with Quality Events/CAPA, document management, training, and change control and ensure appropriate escalation of adverse trends.
Stay up to date with regulatory changes and maintain compliance of the QMS with the evolving regulatory environment.
Inspection Readiness
Support Self Inspections, GXP Internal audits and Global Health Authority Inspections as required. Roles include support in back room, scribe, QMS SME, eDMS SME and eQMS SME.
Serve as a key contact for QMS related inquiries from regulatory agencies, managing responses by partnering with GxP Quality Leaders.
Continuous Improvement
Partner with key functional areas in the organization to enhance the use of the electronic QMS system and to ensure consistent application of system practices.
Foster a culture of continuous improvement within Global QMS.
Implement tools and methodologies to drive process efficiencies and quality improvements.
Cross Functional Collaboration
Partner closely with departments across the business, including R&D, Regulatory, Manufacturing, Supply chain, to integrate quality standards and enhance the use of the eDMS and eQMS to ensure consistent application of practices across Amicus.
Communicate effectively to influence and impact the organization positively at all levels of the organization.
Partner with business to develop and effectively manage department budget
Leadership
Provide strong leadership, direction and development in line with Amicus behaviours to ensure employees are engaged and able to excel in their performance.
Foster a collaborative ream environment to ensure that the QMS team is functioning cohesively and efficiently.
Requirements
Educational Requirements
A minimum of a bachelor’s degree preferably in chemistry or life sciences or an advanced degree.
Professional Work Experience
Demonstrable experience in positions of increasing responsibility in bio/pharmaceutical Quality Assurance.
Proven direct and indirect management level experience including senior level project planning/budget management.
Proven experience in Complaints, Quality Management Systems and/or Auditing.
Demonstrated knowledge with GxP regulations and guidance; 21 CFR, ICH, EU, HIPAA, Part 11/Annex 11.
Demonstrated ability to interact with Global Health Authorities.
Experience in working with global third-party service providers and international call centres.
Experience in quality metrics reporting, analysis and process improvement techniques.
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.
Demonstrated strength in influencing and negotiation skills and ability to communicate effectively at all levels of the organization is required.
Ability to perform in a team and matrix organization, as well as adapt to a dynamic environment is required.
Strong verbal and written communication and personal leadership skills.
Experience with Quality Management electronic Systems such as Trackwise Digital, Veeva, and Master Control.
Proficient with computer usage and applications such as Microsoft Word, PowerPoint and Excel.
Ability to work independently and to make decisions based on experience.
Other skills/Attributes
· Demonstrated alignment with Amicus Mission Focus Behaviors
· Passion for rare disease and patient focused
Travel
· Ability to travel up to 10%.
· This position will be hybrid. Must be able to commute to Marlow, UK. Must be able on short notice to support inspections or other QMS on site activities.
We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all. Our unique experiences, backgrounds and range of cultural perspectives enrich how we approach opportunities, pushing ideas as far and as fast as possible with patients always our top priority. Employee expertise, intelligence, and creativity drives our innovation, and our passion and commitment to excellence. Our “Three Pillars of DEI” are interwoven into our Amicus culture and expands one person, one word, and one act at a time. For our employees, these three pillars are a touchstone for inspiration, guidance, and encouragement.
Amicus is an Equal Opportunity Employer and will judge all applicants based on their qualifications for the job, without regard to race, color, sex, religion, national origin, age, disability, sexual orientation, gender identity, protected veteran, disability status or any other characteristics protected by applicable federal, state or local law.