Manager – Vendor Operations Quality

Manager – Vendor Operations Quality

Requirements

• Applicant must have a high school diploma (or equivalent) and 10 years of relevant experience; OR an associate’s degree with 8 years of experience; OR a bachelor’s degree with at least 4 years of experience; OR a master’s degree with at least 2 years of experience; OR a PhD with 0+ years of experience.
• Substantial experience in pharmaceutical manufacturing and quality control
• Familiarity with Current Good Manufacturing Practices (cGMP) and handling compliance issues arising from cGMP deviations or product defects
• Knowledge of regulations related to vendor management programs and other industry quality systems
• Strong critical thinking skills and a proactive approach
• Ability to collaborate effectively, manage relationships, and communicate well both in writing and verbally
• Advanced computer skills in MS Office applications and a good understanding of enterprise systems such as SMS, eQMS, QTS, GDMS, CLM.

Responsibilities

• Manage GMP or GDP external vendors and contracted services in support of clinical supply and new product development through the lifecycle of the vendor.
• Responsible for new vendor qualification including: Partner with business lines on selection process, assisting with due diligence when required. Completing risk assessments with business lines and vendors to mitigate any risk before qualification risk. Develop qualification strategy by working with business line stakeholders to understand timelines. Lead and or contribute to the generation, maintenance and approval of quality agreements.
• Responsible for all aspects of vendor oversight inclusive of: Site visits and quality review meetings. Generation of oversight plans. Periodic evaluation of performance and determination of qualification status. Monitoring Vendor Performance. Maintaining Vendor information in all GMP systems. Lead exit strategy with partner lines if determination to exit a vendor.
• Lead and guide moderately complex projects, managing time and resources effectively, and apply skills and discipline knowledge to departmental work.
• Make decisions to resolve moderately complex problems, develop new options guided by policies, and operate independently in ambiguous situations.
• Manage vendor deviations, change control providing insight and approval when needed.
• Identify areas for improvement, and facilitate agreements between different teams using leadership skills.
• Assess supplier operations for quality compliance, conduct quality reviews, and report results to relevant business lines and quality groups.
• Participate in internal cGMP audits, support regulatory inspections, and communicate with internal and external customers to resolve vendor related issues.
• Ensure effective internal networking to develop and maintain business partner relationships with internal colleagues.

Preferred Qualifications

• Experience in Quality Systems in pharmaceutical, medical device, or combination product industry
• Knowledge or exposure to data science
• Strong leadership and team management skills
• Ability to work under pressure and meet tight deadlines
• Ability to influence and negotiate with stakeholders
• Experience in conducting internal audits and supporting regulatory inspections