Sunovion Senior Director, Pharmacovigilance QA in Marlborough, Massachusetts

Job Description:

•Leads and optimizes Sunovion’s Global PVQA function that supports Sunovion regional and DSP global products in compliance with ICH Guidelines and international regulatory requirements.

•Develops and maintains PVQA policies and procedures, and provides input and QA oversight for policies and procedures applicable to the broader Pharmacovigilance System.

• Conducts or leads Quality Assurance activities for compliance issue investigations, deviations, training and CAPA.

•In collaboration with quality counterparts globally establishes and executes a global risk-based PV audit program for DSP Companies, contract vendors and third parties working closely.

•Leads inspection readiness and management activities for Sunovion and coordinates global inspection readiness activities for PV inspections of global products.

•Collaborates with global PVRM and quality staff as well as QPPV to ensure global coordination of quality system activities.

•Monitors the global and regional PV Quality System through metrics and reports on the status of the Quality Systems through the Quality Governance structure.

Job ID: 6369BR

Department: QA/QC

Location: Marlborough, MA

Job Type: Full-time

Summary of Responsibilities: •Leads and optimizes Sunovion’s Global PVQA function that supports Sunovion regional and DSP global products in compliance with ICH Guidelines and international regulatory requirements.

•Develops and maintains PVQA policies and procedures, and provides input and QA oversight for policies and procedures applicable to the broader Pharmacovigilance System.

• Conducts or leads Quality Assurance activities for compliance issue investigations, deviations, training and CAPA.

•In collaboration with quality counterparts globally establishes and executes a global risk-based PV audit program for DSP Companies, contract vendors and third parties working closely.

•Leads inspection readiness and management activities for Sunovion and coordinates global inspection readiness activities for PV inspections of global products.

•Collaborates with global PVRM and quality staff as well as QPPV to ensure global coordination of quality system activities.

•Monitors the global and regional PV Quality System through metrics and reports on the status of the Quality Systems through the Quality Governance structure.

Essential Functions: •Establishes and maintains a comprehensive Quality System for global products ensuring compliance with international PV regulatory requirements. Ensures that global and regional documents comply with international regulatory requirements.

•Establishes and maintains a global PV audit schedule of DSP Companies and contract vendors that provide PV services aligned with regulatory requirements. Ensures adherence to annual and long-term audit schedule and development of comprehensive CAPA plans to address audit findings. Tracks completion of audit CAPA’s.

•Conducts PV audits of vendors and third parties in global territories and provides oversight for consultants conducting •Establishes and maintains a comprehensive Quality System for global products ensuring compliance with international PV regulatory requirements. Ensures that global and regional documents comply with international regulatory requirements.

•Establishes and maintains a global PV audit schedule of DSP Companies and contract vendors that provide PV services aligned with regulatory requirements. Ensures adherence to annual and long-term audit schedule and development of comprehensive CAPA plans to address audit findings. Tracks completion of audit CAPA’s.

•Conducts PV audits of vendors and third parties in global territories and provides oversight for consultants conducting audits on behalf of the Company. Coordinates the development and maintenance of appropriate contracts (MSA, SOW, CDAs) for all consultants as required.

•Develops a program to manage deviations and CAPA arising from PVRM activities conducted at DSP Companies or at third party contractors/vendors. Ensures appropriate investigation of deviation events and development of CAPA plans and provides QA approval of Quality System documents. Ensures tracking of deviations and CAPA through completion.

•Leads PV inspection readiness activities for Sunovion and manages inspections and responses. Coordinates inspection readiness efforts for global products and participates in inspection readiness/management activities at DSP Companies and at third party vendors.

•Works closely with PVRM staff and QPPV to ensure compliance to EU PV requirements by providing Quality System data related to the PVRM.

•Plays a lead role in Global PV Audit team and works closely with Quality counterparts that support PVRM at DSP Companies.

•Represents Quality at Global and regional PVRM Meetings and provides guidance on quality related topics.

•Monitors and assesses overall compliance trends and issues for PV systems and processes and provides periodic assessments and trend reporting to management

Minimum Education Requirements: Bachelors

Experience Required: 10+ Years

Knowledge & Skills (General and Technical): Minimum of bachelor’s degree in a scientific discipline (e.g. biology, chemistry, pharmacy) or relevant field of study; or equivalent combination of training and experience in a regulated industry.

Experience

•Must have a minimum of 10+ years’ experience in a regulated biotechnology, pharmaceutical, or medical device company, with a minimum of five years’ experience in PV- related role.

•Previous experience in PVQA auditing required.

•Expert knowledge of ICH, GPvP, US and EU regulations, industry standards and best practices for PV is required.

Previous experience in a global QA environment supporting the PV function.

•Experience in interactions with regulatory inspectors is preferred.

•Must be a hands-on technical professional with a comprehensive understanding of current FDA regulations, and pharmaceutical industry quality standards as well as international expectations for quality systems.

Complexity

•Must be able to interpret and apply regulations to internal procedures and practices, investigate compliance issues, and make/evaluate proposals for solutions.

•Must be able to travel internationally periodically for PV audits, global PVRM meetings and/or regulatory inspections.

Interactions

•All levels within Sunovion Pharmaceuticals Inc. and counterparts at DSP Companies

•Management levels at contract organizations.

Other Requirements (Licenses, Certifications, Specialized Training, Physical or Mental Abilities Required):

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 Sunovion are carried out with the "best" industry practices and the highest ethical standards.

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 computer for extended periods of time.

Sunovion Pharmaceuticals Inc. is an Equal Employment Opportunity (EEO) and Affirmative Action employer

Sunovion is committed to a culturally diverse workforce. All 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, gender identity or expression; 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.