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Sanofi Group Manager, PMF Documentation - Vaccines in Swiftwater, Pennsylvania

Job Title : Manager, PMF Documentation,

Job Profile : Lean and Performance Global / Platform Manager

Division/Business Unit : PMF ( Project Management Function)

Location : MB 18

SUMMARY OF PURPOSE/MAJOR RESPONSIBILITIES:

Briefly describe in two to three sentences the major/overall purpose of the job/ why it exists and what are the major expected results.

The position creates and helps manage change controls, and oversees the revisions, updates, and creation of Quality eDoc documents; i.e., standalone forms, logbook forms, graphic work instructions, Batch Records, Master Specifications, Standard Operating Procedures, along with other critical documents to maintain Product Launch and other Project schedules.

Maintains a strong working relationship with teams; FFIP, QA, PQMR, RA, QC and other departments requiring document support through a foundation of trust, accountability and teamwork.

As part of the organization, this role does the following:

  • Individual contributor role that is member of cross-functional teams that provide support for the Product Launch efforts

  • .Manages the Product Launch Change Control and Documentation Workload that they are assingned.

  • Oversees and provides direction to find resolutions to problems impacting the document process.

  • Coordinates/tracks all official documentation review and approval workflows within Quality eDoc ensuring deadlines are met.

  • Tracks Change Controls action items within the Phenix system and is responsible for Action Item closures.

  • Oversees the authoring of Batch Records, Master Specifications, Standard Operating Procedures, Standard Work Instructions, and other critical documents in conjunctiuon with FFIP team..

  • Participates in scheduled training and stays abreast of Sanofi best practices.

  • Regularly meets with SMEs to determine subject material to be written, regarding documentation and updates.

  • Provides status updates of documents and other quality systems.

  • Participates as a project core team member that has document impact.

KEY ACCOUNTABILITIES:

  • Provides Change Control and Documentation support to the Product Launch teams and C & M (Current and Major) Projects. Product Launches and C & M projects are small/medium projects. Product Launches involve launching existing or new products into existing or new markets. C & M projects are small to medium size Capital projects. This organization will provide project support to accomplish these efforts. These projects typically take place in the FFIP environment and require a close interface with FFIP team. - 75% of time

  • Attends project meetings to provide updates and gather information needed for change controls and documentation. - 20% of time

  • Ensure compliance with all regulatory requirements and good documentation practices are followed to provide a safe, quality, and effective product. - 5% of time

CONTEXT OF THE JOB/MAJOR CHALLENGES:

  • Manage multiple change controls and documents for various product launches.

  • Strong autonomy required to speak, decide and provide leadership on behalf of (or in support of) Production Unit.

  • Experience with normal Sanofi business processes, including but not limited to: Quality Geode, SAP, Phenix, Trackwise, Sharepoint, eBuy.

  • Demonstrates strong oral and written communication skills.

DIMENSIONS/SCOPE:

  • The Manager, Continuous Improvement is responsible to contribute to the operating expense budget of approximately $3M.

  • This position has no direct reports.

  • Participates in Continuous Improvement efforts and support FFasT teams responsible for Technical support in FFIP.

REQUIREMENTS:

Education/Experience:

  • BS or MS required in Life Sciences or Engineering

  • 3+ years large scale biotech or pharmaceutical, manufacturing, maintenance, engineering, analytical & process development experience

  • The individual should have worked with Operations personnel for at least 5 years with increasing levels of responsibility and have a good understanding of current GMP/GLP, Continuous Improvement methodologies, and common issues addressed to achieve Operational Excellence

  • Must have excellent written and verbal communication skills, as well as the ability to actively, and cooperatively work with cross functional teams.

Preferred Qualifications:

  • A minimum of three to five (3-5) years working with documents in a regulated environment.

  • Excellent interpersonal and communication skills.

  • Attention to detail.

  • Ability to manage conflict and develop customer solutions.

Competencies:

  • Entrepreneurship - Level 1

  • Change and Innovation - Level 1

  • Team Performance - Level 1

  • Effective Communication - Level 1

  • Company Spirit - Level 1

  • Strategic Thinking - Level 1

Job Specific:

  • Project Delivery and Management - Level 1

  • Formulation, Filling and Inspection Technical Knowledge - Level 1

  • Building Utilities Knowledge - Level 1

  • Customer Support - Level 1

  • Operational Experience - Level 1

  • Ability to prioritize amongst many good improvement opportunities - Level 1

  • Demonstrates strong oral and written communication skills - Level 1

Sanofi Inc. 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.

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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

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