Senior Manager, Gmp Compliance

Skills Alliance is partnered with a pre-commercial pharmaceutical company who specializes in innovative therapeutics for chronic liver, gastrointestinal and inflammatory disease.

POSITION SUMMARY

The Sr. Manager, GMP Compliance will be responsible for conducting internal and CMO/CDMO audits, assisting in inspection/audit preparation activities, and supporting GMP regulatory inspections for clinical and commercial programs. As part of the inspection readiness program, the Senior Manager evaluates external guidance and regulations, ensures visibility and awareness of emerging new or changing standards. The Senior Manager works with internal functional groups and CMO/CDMOs to support global activities and provides cGMP compliance audit trends and metrics to Management. This is a hands-on role reporting to the VP of Quality.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Complete other responsibilities, as assigned.
• Supports regulatory inspections in the creation, maintenance and management of inspection content, ensuring it is organized, current and readily accessible at all times.
• Responsible for planning managing and conducting internal and external GMP audits of CMOs/CDMOs per defined timelines.
• Develops and provides meaningful metrics and trends to Management.
• Lead proactive evaluation and education of site GMP compliance against current and emerging regulatory trends.
• Collaborates with management to identify, evaluate, and recommend solutions to issues identified during performance of GMP audits.
• Work collaboratively with commitment owners to ensure that all commitment timelines are met via proactive CAPA tracking, and confirm their timely closure and ensure suitable effectiveness checks are implemented.
• Ability to apply principles of logical and scientific thinking to a wide range of technical and practical small molecule manufacturing applications.
• Evaluate and manage proposed commitments to regulatory authorities/audit bodies in response to inspection/audit findings.
• Acts as a central point of control for the resolution of internal and external audit findings while ensuring audit reports are issued and debriefs conducted in a timely manner.

MINIMUM QUALIFICATIONS

• Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully.
• Excellent interpersonal skills, including listening, writing, negotiating positions, facilitating discussions, possess great attention to detail.
• Follows instructions and responds to management direction; Takes responsibility for own actions.
• Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
• Working Knowledge and experience with 21CFR210 & 211, ICHQ7, 21CFR600,21CFR11, Eudralex Vol. 4, as well as other international regulations scientific and business professionals who are highly motivated, collaborative.
• Ability to travel up to 20-30% domestically
• Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent change, delays, or unexpected events.
• Requires 6+ years of relevant experience, preferably in the pharmaceutical or biotech industries or related field or equivalent.
• Excellent computer proficiency (MS Word, Excel, PowerPoint)
• Communicates changes and progress; Completes tasks on time or notifies appropriate person with an alternate plan.

EDUCATION, CERTIFICATES, LICENSES, REGISTRATIONS

• Bachelor of Science degree
• Certified Quality Auditor is desirable

Interviews will be set quickly; For further details and a full job description please email Kristin Vollmer at [email protected]. All queries are treated confidentially.