Quality Systems & OPEX Manager (Change Management)

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• Partner cross-functionally to support the execution and lifecycle management of a compliant and effective Pharmaceutical Quality System (PQS).
• Own and lead the management and lifecycle of QMS Change Control, including oversight of global and local Change Control Review Boards (CCRB).
• Support review and approval of GxP IT system change controls and validation documentation.
• Identify, trend, and communicate quality process and IT system metrics. 
• Act as a process owner for Quality Management System processes.
• Act as an IT system superuser where applicable.
• Apply continuous improvement principles to strengthen processes and reduce regulatory risk.
• Provide direct oversight and influence for owned PQS processes.
• Support changes and additions to SOP, Work Instruction, and like controlled documents.
• Assist in providing training support for new and existing employees for owned processes. 
• Support regulatory inspection readiness and participate in inspections as required.
• Minimum 10% travel.

• Bachelor of Science degree in a relevant scientific discipline from an accredited university required.
• Minimum eight (8) years of quality experience in a regulated industry.
• Broad knowledge of current GMPs, regulatory requirements related to international standards including GAMP5, EU, Health Canada, TGA, ICH, PIC/S.
• Proven ability to work under pressure without compromising deliverables.
• Excellent written and verbal communication skills.
• Proactive, organized, and dependable working style.
• Confidence influencing outcomes without direct authority.
• Proficiency with Microsoft tools; Visio and eQMS experience a plus.
• Lean Six Sigma Green Belt certification or Project Management certification preferred.
• Ensure Quality SharePoint sites and intranet sites are maintained.
• Proficiency in conducting Risk Assessments to support deviations, change management and CAPA.
• Strong and confident negotiator understanding optics and soft skills within a corporate environment.
• Excellent team player, able to work across boundaries to accomplish goals set.
• Excellent interpersonal and communication skills with peers and senior management.
• Logical, process-based thinking necessary to work effectively in role.
• Able to understand different perspectives and deliver the best outcome for the business.
• Role that works across all functions where there is GxP responsibility.

• Competitive PTO plus company closure from December 24th- January 1st 
• 401(k) and Profit-Sharing Plan- Company match of 75% on your first 6% of contributions and profit-sharing contribution equal to 4% of your eligible pay 
• U.S. Employee Stock Purchase Plan- 15% Discount 
• Comprehensive Medical, Dental, Vision, Life and Disability coverage 
• Health, Dependent Care and Limited Purpose Flex Spending and HSA options 
• Adoption assistance 
• Tuition reimbursement 
• Concierge/personal assistance services 
• Voluntary benefits including Legal, Pet Insurance and Critical Illness coverage 
• Wellness programs as well as other discounts and perks

• Have unquestionable ethics and integrity with the willingness to stand firm on these principles even under significant pressure 
• Risk IQ: Know what policies apply to your role and function and adhere to them. 
• Speak Up: If you see something, say something. 

• Have unquestionable ethics and integrity with the willingness to stand firm on these principles even under significant pressure 
• Reinforce risk awareness with your team, with accountability and oversight for ongoing review and mitigation. 
• Model and reinforce a Speak Up culture on your team.