Project Manager, QA Validation

Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.

Summary: Validate/qualify equipment, systems, and processes in accordance with regulatory requirements and support, follow and implement company manufacturing standards policies and procedures.

Essential Duties and Responsibilities include, but are not limited to, the following:

• Responsible for compliance monitoring of area operations, including trending of failures and evaluating effectiveness of corrective actions.

• Generation of validation project deliverables and schedule, including integration of deliverables/schedule into larger project team plan.

• Evaluates milestone achievement versus schedule plan, and translates information to reportable metrics.

• Formulates efficiency improvement to ensure timeliness of validation deliverables.

• Ability to concisely deliver project reports to management.

• Generates executes and/or reviews master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria.

• May prepare equipment for qualification studies and executes qualification and validation studies according to approved protocols and SOPs. Analyzes the results of testing and determines the acceptability of results against pre-determined criteria.

• Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements.

• Reviews, edits and approves deviation notifications, deviation investigations, and corrective actions.

• Reviews, edits and approves change control and SOPs.

• Collaborates with functional departments to resolve issues.

• Coordinates with other departments or outside contractors/vendors to complete validation tasks.

• May trains/advise less experienced personnel.

• May directly supervise contingent workers.

• Provides direction and assigns work to full time employees and contingent workers to meet goals and deadlines. Coordinates with other departments or outside contractors/vendors to complete validation tasks.

• Manage and drives projects and programs.

• Presents project and program status and metrics to Senior Management. Act as Technical Subject Matter Expert (SME) in at least one area (e.g. SIP Qualification, Cleaning Validation, Lab Equipment Qualification, Cleanroom Qualification)

• Must be able to present in a "pressure test" scenario the technical area that they are SME for

• May present at both internal and external (regulatory) audits

• Stays current with industry trends, regulatory requirement updates, and drives changes and improvements based on trends.

• May include other responsibilities as required by business needs.

• Travel may be required.

Knowledge, Skills & Abilities:

• Ability to maintain integrity and honesty at all times

• Ability to work independently or as part of a team

• Ability to communicate with transparency

• Continuously drive to improve processes for improved performance

• Demonstrate respectful behavior at all times

• Accountable for technical performance and results of team

• Manage internal and external relationships

• Develop strategy and create metrics to measure effectiveness of strategy

• Translate ambiguity into actionable steps

• May manage others through influence rather than direct authority

• Ability to resolve conflicts and coach others on problem solving

• Handle issues appropriately and with a sense of urgency

• Prioritize based on business needs

• Identify and effectively communicate risks

• Ability to problem solve and identify root cause

• Ability to communicate at all levels and across various functions

Education and Experience:

• Associate Project Manager level - BS/BA in Engineering, Chemistry, or Life Sciences with 8+ years of related experience within the field preferred; will substitute relevant experience for education.

• Project Manager level - BS/BA in Engineering, Chemistry, or Life Sciences with 10+ years of related experience within the field preferred; will substitute relevant experience for education.

*Level will be determined based on skills and related experience.*

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.

To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.
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