Be the next big change > Dassault Systèmes

Be the Next Game Changer

Director, BIOVIA Quality Compliance & Risk

United States, MA, Waltham
Regular
2/27/2022
525074

In this role, the Compliance & Risk Director ensures that BIOVIA life science software solutions meet the quality standards and regulatory requirements demanded by our world-class life science customers, in accordance with the 3DS BIOVIA Quality Management System (QMS). 

As a member of our Quality Compliance team, you will be responsible for maintaining and improving a scalable QMS system that supports the definition, development, testing, and release of software solutions deployed in regulated industries.  Using industry experience to provide compliance guidance and oversight, the Compliance & Risk Director will manage expectations with customers regarding how BIOVIA’s cloud software can support their compliance needs.

 

Hosting customer audits, defining CAPAs, and representing BIOVIA in customer engagements and industry bodies related to quality and regulatory compliance are an important part of this role.  Other key activities include project management, SDLC tools administration, data analysis, trend-reporting and conducting RCA identification and closure.

 

Successful candidates will have experience in the life sciences industry authoring SOPs, managing a quality system, validating software, managing change control, and defending internal QMS practices to regulatory agencies such as FDA, MHRA, or EMA.

Imagine New Horizons…

 

BIOVIA, a Dassault Systèmes digital solutions brand, provides global collaborative product lifecycle experiences for organizations and industries that rely on scientific innovation for competitiveness.  BIOVIA’s leading scientific enterprise software solutions enable scientific innovation at the world’s leading pharmaceutical, biotechnology, chemical, and petroleum companies.

What will your role be?

 

In this role, the Compliance & Risk Director ensures that BIOVIA life science software solutions meet the quality standards and regulatory requirements demanded by our world-class life science customers, in accordance with the 3DS BIOVIA Quality Management System (QMS). 

 

As a member of our Quality Compliance team, you will be responsible for maintaining and improving a scalable QMS system that supports the definition, development, testing, and release of software solutions deployed in regulated industries.  Using industry experience to provide compliance guidance and oversight, the Compliance & Risk Director will manage expectations with customers regarding how BIOVIA’s cloud software can support their compliance needs.

 

Hosting customer audits, defining CAPAs, and representing BIOVIA in customer engagements and industry bodies related to quality and regulatory compliance are an important part of this role.  Other key activities include project management, SDLC tools administration, data analysis, trend-reporting and conducting RCA identification and closure.

 

Successful candidates will have experience in the life sciences industry authoring SOPs, managing a quality system, validating software, managing change control, and defending internal QMS practices to regulatory agencies such as FDA, MHRA, or EMA.

Your Challenges Ahead

  • Provide strategic input into the compliance and security posture at the global corporate and brand levels supporting customers in the life sciences industry
  • Champion and influence process and tools improvements across brands and corporate
  • Develop, maintain, improve compliance processes; conduct management reviews on compliance status and risk
  • Conduct internal audits and release compliance reviews to ensure compliance with QMS processes, collaborating with peers and across functions.  Includes developing audit plans, audit findings, and audit reports.
  • Manage external audits as assigned, including effective planning and execution, as well as responding to auditor questions.  Includes official responses to audit findings
  • Manage internal and external audit findings and monitor corrective actions resulting from compliance reviews and audits to drive continual improvement and improve the effectiveness of BIOVIA QMS processes and controls
  • Manage CAPA program, creating CAPAs in collaboration with process owners, monitoring CAPA plans and closure activities.
  • Fulfill customer compliance requests and RFP questionnaires to customer satisfaction 
  • Manage the GxP validation process, including planning, oversight, change management, compliance reviews, quality deliverable packaging for customer release within a continuous cloud delivery model
  • Represent BIOVIA R&D on compliance topics with external parties including customers, partners, and industry groups. 
  • Provide consulting to R&D teams to improve compliance and risk and drive continual improvement 
  • Promote compliance awareness and expectations and support training programs globally across BIOVIA R&D, Support, & Professional Services teams

Your Key Success Factors?

  • Education:  BS in life science, computer science or engineering related fields
  • 15+ years in quality compliance in software or life science industries including FDA/EMA regulated environments
  • Comprehensive knowledge of 21 CFR Part 11, Annex 11, cGLP and cGMP regulations and the ability to correctly interpret minimum standards relative to software is a must
  • Distill Industry regulations and customer compliance expectations into the relevant compliance needs for software providers (e.g., GxP for life sciences)
  • Strong understanding of GAMP 5 principles and CSV in a GXP context
  • Influenced, participated and presented in working groups and forums such as GAMP 5
  • Strong people management skills
  • Experience working in a virtual cross-functional team environment is required
  • Ability to communicate effectively with leadership and individuals up, down and across the organization and at global locations
  • Strong leadership skills, including ability to lead change efforts through effective communication and persuasion
  • Experience supporting QMS and ISMS processes and familiarity with industry certification including ISO 9001 and ISO 27001
  • Administrator experience with document management and SDLC tools such as QUMAS and JIRA/Confluence or similar
  • Understanding of software development methodologies and best practices, including the use of scaled agile (SAFe) and cloud continuous software delivery models within regulated software
  • Attentive to details; focused on accuracy and traceability in compliance reviews
  • Experience with risk management methodologies and best practices
  • Enjoy championing process improvement and automation efforts, working with cross functional teams
  • Certified Quality Auditor from ASQ is highly desirable

Compensation & Benefits

Dassault Systèmes offers an excellent salary with potential for bonus, commensurate with experience. Benefits include a choice of plans providing comprehensive coverage for medical, dental, vision care for employee & dependents as well as employee life, short & long term disability, tuition reimbursement, immediate 401K enrollment, 401K match (50 cents on the dollar, up to the first 8% of your eligible compensation that you contribute based on match eligibility criteria), flexible time off policy, and 9 paid holidays.

Equal opportunity

In order to provide equal employment and advancement opportunities to all individuals, employment decisions at 3DS are based on merit, qualifications and abilities. 3DS is committed to a policy of non-discrimination and equal opportunity for all employees and qualified applicants without regard to race, color, religion, gender, sex (including pregnancy, childbirth or medical or common conditions related to pregnancy or childbirth), sexual orientation, gender identity, gender expression, marital status, familial status, national origin, ancestry, age (40 and above), disability, veteran status, military service, application for military service, genetic information, receipt of free medical care, or any other characteristic protected under applicable law. 3DS will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Covid statement

Our Company requires all U.S. employees to be fully vaccinated against COVID-19 and to provide documentation of full vaccination, unless qualified for a medical, religious or state-required accommodation or otherwise exempt consistent with applicable law.  Although accommodation requests will be considered (and granted where appropriate/possible), it may be determined that a candidate is unable to adequately perform the essential functions of the position without imposing an undue hardship due to customer requirements, staffing needs, or other business reasons. Definition of full-vaccination: Employees are considered to be fully vaccinated two weeks after their second dose in a 2-dose series or two weeks after a single-dose vaccine.
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BIOVIA provides scientific solutions to discover, design, develop and deliver innovative drugs, materials and formulas.