Sanofi Group Senior Manager, Document and Records Control in Allston, Massachusetts

The Quality Systems department manages Change Control, Document Control and Records Management, Product Quality Reviews, Quality Management Review, Quality Engineering, the Deviation/CAPA Systems, and Quality Information Systems (QIS) activities.

Specifically, Document and Records Control group manages all aspects of the document and records management lifecycle including creation, issuance, revision, retentionand archival. In addition the group functions as the owner of the Document Control and Records Management systems at the Allston Landing Facility.

Directly responsible for the daily operations of the Document Control and Records Management function as they relate to the GxP controlled documents and records lifecycle, including the creation/modification, approval, distribution/issuance, archival, retrieval and destruction of documents and records at Allston Landing.

Develop training strategies and materials that support continuous improvement initiatives and provide them to the users of the system.

Provide subject matter expertise and support during regulatory inspections, internal audits, site project portfolio strategies and execution as it pertains to document changes and implementation. Identify major issues, if present, escalate to senior management and design solutions to address and report on progress.

Provide system oversight and ensure system compliance and usage to regulatory, corporate and site requirements as they related to document control and records management.

Ensure system access is controlled and effectively monitored.

Ensure system health and continuous improvement by the incumbent by establishing and enabling appropriate strategies.

Provide regular metrics and trending reporting including corrective measures as needed.

Perform annual system health assessments. Establish annual roadmaps generated from the system health assessments and site goals that establish continuous improvement strategies and solutions.

Represent Allston Landing in the cross-site document control and records management Community of Practice (CoP). Actively engage in other multi-site forums and establish mechanisms of acquiring expertise, e.g., monitoring of industry trends and practices, to ensure Allston Landing facility processes reflect industry best practices.

Manage direct reports including participation in in goal setting, performance and talent reviews and career development of personnel. Administer work load and report to assure all department related activities and timelines are met. Ensure training for staff is current with all regulations (cGMP).

This position provides technical expertise and high-level decision making that impacts the effectiveness of this pillar quality system and a broad array of functional areas and partners (both internal and multi-site) that engage with this system. Building strong, collaborative relationships with these customers via effective communication and influencing skills is central to the success in this role.

Leadership Qualifications:

Leading People

* Sanofi's leaders motivate, inspire, build, and retain highly effective manufacturing teams while managing for high performance and developing others. They are versatile learners and courageous decision makers

Leading the Business

* Sanofi's leaders are effective operating in an evolving, complex and dynamic environment, providing clear direction and instruction to direct reports, and continuously looking internally and externally for best practices and areas for improvement.

Delivering to Customers

* Sanofi's leaders understand patient and customer needs and build relationships as required to meet manufacturing goals while continuously improving operations by setting high standards for the team so to a level of excellence.

Basic Qualifications:

• Bachelor’s Degree with 8 years of experience in GMP or other regulated environment or Master’s Degree with 6 years of experience in GMP or other regulated environment.

• 3 years of experience in a management role

Preferred Qualifications:

• Degree(s) in Engineering or Life Sciences preferred

• 3 years of experience directly supervising or managing Document Control and Records Management within a GMP environment

• 3 years experience a Quality role in a GMP environment

• Experience serving as Subject Matter Expert (SME) in regulatory inspections

• Experience performing work that consistently requires independent decision making and the exercise of independent judgment and discretion in a cGMP environment

• Experience operating in an environment with strict timelines

• Experience presenting to large groups in areas of subject matter experience

• Strong written and verbal communication skills and ability to influence colleagues and management in a cross-functional environment

• Experience generating process metrics and reports.

• Proficient in Microsoft Office applications and graphics

Genzyme Corporation (a Sanofi company) and its U.S. affiliates are Equal Opportunity and Affirmative Action employers 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.

Sanofi is a global healthcare leader focused on patients' needs, engaged in the research, development, manufacturing and marketing of therapeutic solutions focused on patients’ needs. Sanofi has core strengths in diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets and Sanofi Genzyme.

At Sanofi, our ambition is to be an integrated global healthcare company, focused on patients’ needs. Much more than just a leading pharmaceutical company, Sanofi is committed to transforming scientific innovations into solutions and services that protect health, enhance life, and respond to the needs of the 7 billion people in the world. We trust our ambition to guide and inspire us as we work to create a future with optimal health and wellness for everyone.

Sanofi is a global healthcare leader focused on patients' needs, engaged in the research, development, manufacturing and marketing of therapeutic solutions focused on patients’ needs. Sanofi has core strengths in diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets and Sanofi Genzyme.