Senior Manager, Quality Assurance
About Servier Pharmaceuticals:
We're an organization, committed to modeling diversity, equity, and inclusion for the entire industry, and to maintaining an inclusive environment with equitable treatment for all. We are interested in growing our team with passionate, committed, and innovative individuals. We encourage all to apply to our open roles and are always willing to consider skills and experiences outside of what is listed in the job description.
SUMMARY OF ROLE:
The Quality Assurance Lead is responsible for leading the VPT quality group members to provide quality oversight of production and testing of commercial products at Contract Manufacturing Organizations including quality support of Technology Transfers, Continuous Improvements and regulatory submissions.
Specific Responsibilities:
Quality Leadership
Provide expertise and guidance to Servier departments in interpreting and implementing governmental and agency guidelines to ensure GMP compliance
Provide QA input to the Global Industry team and facilitate the escalation of quality events as necessary
Ensure GMP audit readiness at CMOs
Provide QA input to External Manufacturing Leadership Team and company strategic goals in the form of schedules, planning, and budgeting
Enable direct reports to execute their assigned responsibilities
CMO and CLO Quality Oversight
Provide GMP QA oversight of vendors and maintain quality agreements
Ensure audits of contract locations are performed per the Industry Quality audit schedule
Support GMP audits and regulatory inspections
Ensure manufacturing is completed on time and according to specifications and GMP. Provide QA support and impact assessments for deviations and other quality documents as needed
Build relationships with Quality partners at CMOs ensuring quality issues are tracked and resolved in a timely manner.
Perform quality due diligence and vendor qualification activities
Oversee batch record review and release
Ensure that batch disposition turnaround times and Right First Time are tracked and aligned to targets
Engage in activities to continuously assess and improve Lot Review and Disposition processes.
Product Strategy, Operations, and Execution
Execution of quality strategy deliverables
Ensures communication of QA External Manufacturing strategic decisions to VPT Quality representatives
Enables seamless quality deliverables, escalations, and helps identify and remove roadblocks
Stewardship and understanding of the product's quality performance, risk and associated interim controls and mitigation
Stewardship of quality milestones and deliverables for Lifecycle quality management execution
Regulatory submission and specification review & approval
Other duties as required or directed by the Manager or Functional Management
Skills and Education:
BS in Scientific /Engineering field, or relevant experience
Minimum 10 years in CMO Quality Experience in small or large molecule
Experience in managing Contract Development / Manufacturing Organizations and external partners.
Strong experience in a multi-functional team role utilizing risk management processes
Experience with pharmaceutical development, process scale up and optimization, packaging aspects, technology transfers and analytical techniques preferred
Demonstrated project (set and prioritize goals, identify deliverables, perform risk/gap assessments and manage stakeholders) and program management capabilities (Strong ability to strategically plan, organize, and manage multiple projects simultaneously.)
High Quality Assurance GMP experience.
Expertise in use/application of variety of problem solving (DMAIC, Six Sigma) tools e.g. Ishikawa, Kepner-Tregoe (KT), five-whys, etc.
Demonstrates proficiency with lean practices and standard work and processes
Well versed in GMP environment and current FDA / EU regulations with strong knowledge of relevant GxPs as well as applicable multinational regulatory guidelines.
Prior experience working in Virtual Plant Team Models a plus
Effective communication with ability to influence others at every level in a highly scientific and technical environment (written and verbal) including diplomacy, negotiation skills.
Collaborates well with other areas of the business
Ability to build authentic relationships internally, with external vendors/third party suppliers, and with regulatory agencies
Ability to work both independently and under supervision in a timely manner
Demonstrated track record of creativity and problem solving in projects.
Ability to work in interdisciplinary teams with strong interpersonal skills
Ability to lead by example, attract and develop talent, build interdependent partnerships, and create a culture of collaboration and teamwork that fosters open communication, constructive conflict resolution and organizational flexibility.
Effective communication with ability to influence others at every level (Persuasive) in a highly scientific and technical environment (written and verbal) including diplomacy, negotiation skills.
Excellent interpersonal skills needed to work in a high-performance culture
Ability to manage and resolve conflict
Demonstrates leadership capability
Demonstrates a solution-oriented mind set
Fluent speaking and writing English
Demonstrate cultural sensitivity and an understanding of the global practices where business is conducted
Can make critical decisions around business plans, investment, and resolves very complex problems.
Shows ability to look at data more critically and draw meaningful conclusions.
Demonstrates a confirmed capability to set the direction for the function/business, drive engagement and large group alignment around business plans.
Other Relevant Information:
Approximately 25% domestic and international travel is required to meet the needs of the business
Position is located within the Servier Industry Quality organization with headquarters located in Boston, MA, Anpharm, Poland, or France