Senior Director, Quality Assurance

Job Overview

The Senior Director of Quality Management Systems will oversee the development, implementation and maintenance of the Company’s global GxP quality management system designed to comply with applicable laws and regulations, ensure compliance to the strategy through training and regular management reviews including quality metrics, and direct the functional resources needed to execute this strategy. Directs the development, implementation, and maintenance of quality systems (e.g., vendor management, internal and external audits and inspections, investigations, CAPA, metrics, etc.) and activities. Establishes objectives for the QMS function in line with and in support of company products. Leads the deployment of an electronic QMS to support all Quality related activities including, but not limited to deviations, investigations, metrics and product quality complaints. Partners with internal stakeholders to ensure the eQMS functionally supports cross functional teams and the Company’s processes.

Job Duties and Responsibilities

• Oversee the development and maintenance of a Quality Management System in full compliance with all regulatory requirements.

• Ensure the development of QA systems are effective and in accordance with all government regulations and in compliance with GxPs.

• Lead Management Reviews and routine Quality metrics reporting to monitor Quality System performance and identify areas for continuous improvement.

• Manage the development and implementation of all necessary GxP related manuals, policies, processes/procedures and work instructions.

• Provide guidance and direction on procedures and requirements for meeting applicable regulations and standards.

• Provide oversight, as needed, on eQMS processes associated with deviations, investigations, CAPA, product complaints, risk management and change control as related to manufacturing and other GxP operations.

• Ensure vendor oversight through audits, supplier qualification program and on-going performance management.

• Ensure the organization remains in an Inspection Readiness state by managing an internal audit program for all GxP areas.

• Manages Inspection Readiness activities and play a leadership role in partner audits and regulatory inspections.

• Assist in the management of regulatory agency inspections.

• Manage personnel in all accountable departments with a focus on retention, development and promoting a Quality culture.

• Monitor industry trends and regulatory expectations to ensure evolution of the Quality Management System and compliance strategy.

• Establish and maintain a positive working relationship within the Company and with their external business partners as it relates to area of responsibility.

• Develop strategies and operational tactics for quality initiatives.

• Other duties as needed.

Key Core Competencies

• Bachelor’s degree or related science discipline required; Advanced degree (MS, PhD, MBA) preferred.

• 15+ years of experience working in the Pharmaceutical/Biopharmaceutical industry with at least 5 years in a leadership role managing quality systems.

• Experience in multiple disciplines within Quality (e.g. auditing, investigations, complaints, cGxP oversight, electronic systems management, PAI inspection

• readiness, commercialization and leadership)

• Must have in-depth knowledge of FDA guidelines and have a proven track record in implementing these guidelines in fast growing environments.

• Significant work experience in a pharmaceutical, cGMP environment is required, strong working knowledge of FDA requirements and guidance documents.

• Experience in evolving cGMP related quality systems, policies and procedures to ensure compliance with evolving standards as well as improving the efficiency of related workflows.

• Demonstrated leadership successes in building and creating functions and infrastructure.

• Experience with external CMO environments and as a part of a Quality team.

• Strong ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations.

• Possess strong conflict management and negotiation skills.

• Excellent verbal and written communication skills

• Self-motivated, able to work independently and be reliable and responsive.

The base salary range for this role is $216,400 to $270,500.  Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state.  Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter.  Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law.

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Confidential Data: All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.

Compliance: Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Mental/Physical Requirements: Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.

Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) employer

Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.