Job Title: Quality and Compliance Oversight Specialist
Purpose:
The purpose of this role is to provide quality and compliance oversight of contract labs, CMOs or raw material SREs.
Alignment:
This role must align with the company's CTA (Commercialization & Technical Applications) and Marketing Application.
Responsibilities:
* Negotiate and approve quality agreements for contract manufacturing sites.
* Lead the preparation of the site for product-specific regulatory inspections and/or Notified Body audits.
* Present on topics during inspection, demonstrating appropriate behaviors and knowledge of subject areas.
* Review and approve Master Batch Records, deviations, change controls, CAPA, and other quality-related documents.
* Identify and mitigate risks at the CMO or testing laboratories and escalate to management as necessary.
* Perform Person in Plant activities, manage audit commitments, and support tactical batch disposition activities.
* Making decisions regarding batch release, deviation approval, and quality agreement renewal.
* Provide a quality position on GMP-related topics and strategy for the site.
Requirements:
* A Doctorate degree with 2 years of directly related experience, or a Master's degree with 4 years of experience, or a Bachelor's degree with 6 years of experience, or an Associate's degree with 10 years of experience, or a High School diploma/GED with 12 years of experience.
* At least 10 years of biotech or pharmaceutical industry experience.
* Additional European languages are desirable but not essential.
* SIGNIFICANT QUALITY EXPERIENCE AT ASEPTIC MANUFACTURING FACILITIES IS REQUIRED
Preferred Requirements:
* Familiarity with basic project management tools.
* Ability to negotiate a strategic position after taking feedback from multiple sources.
* Strong project management, problem-solving, and analytical skills.
* Demonstrated ability to lead cross-functional teams and deliver high-quality results on time.
* Collaborates and communicates well with others, able to balance divergent inputs from various stakeholders and drive issue resolution.
* Experience driving decision-making by using DAI principles.
* Experience with the variation management process.
* Skills in Quality Compliance, Labs, Biotech Industry Management.