Senior Manager R&D External Partners Oversight (all genders) (full-time)

Purpose:

Primarily responsible for providing leadership and direction and performing evaluations for compliance with worldwide regulatory requirements; providing relevant and constructive evaluation of Clinical external suppliers that provide materials and services to AbbVie.

Provides leadership direction and execution in compliance and quality; assures that activities are performed and documented in accordance with applicable worldwide quality and regulatory requirements e.g.: Good Clinical Practice (GCP) to assure quality effectiveness and safety of our medical device clinical materials and drug development suppliers.
 

Responsibilities:

• Assess compliance with applicable regulations through supplier oversight activities. The strategic focus is for early detection and prevention followed by correction of issues.
• Interpret explain and apply applicable current governmental regulations guidelines policies and procedures as applicable to associated activities.
• Manage Clinical Quality Agreement life cycle; lead the creation of the Clinical Quality Agreement; lead the conduct of cross-functional periodic review evaluations of Clinical Quality Agreements to ensure that the Agreements remain current; withdraw/terminate Clinical Quality Agreements as applicable
• Provide an active role within R&D as an expert in GCP requirements.
• Collaborate with R&D functional areas and assist in the resolution of external supplier quality issues.
• Prioritize activities to ensure objectives of studies/programs are met. Maintain project oversight to include awareness of project timeliness.
• Lead or participate in technically complex and strategic cross functional projects.
• Lead or participate in strategic initiatives to improve compliance to regulatory requirements and standards.
• Achieve a difficult balance of involvement independence and objectivity.
• Collect analyze and report metrics pertaining to External Partners Quality
• Consistently demonstrate AbbVies Ways of Working and Leadership Attributes including a collaborative mindset and leadership. Create a learning environment embrace the ideas of others and manage innovation to reality.

Qualifications :

Qualifications:

• Bachelors Degree preferably in technical or scientific area (Chemistry Pharmacy Biology Microbiology or Engineering) or equivalent industry experience (at least 8 years) with sufficient exposure to medical device or combination product related industries.
• Thorough understanding of clinical e.g. GCP international regulatory standards. Understanding of GMP GLP GDP GCLP) and Medical Device regulations and standards optional.
• Must have a technical background and a thorough understanding of the supplier oversight.
• Must understand a variety of quality/operational systems that support study/product design device development and understand the principles of quality management.
• Must have excellent oral/written communications skills interpersonal skills leadership tact open mindedness maturity tenacity decisiveness self-reliance organizational / administrative skills and sound judgment.

Additional Information :

AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. 

US & Puerto Rico only - to learn more visit  & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

No

Employment Type :

Full-time