** fulltime/hybrid

Philadelphia PA

Our client seeks an exceptional talent to play a pivotal role in expanding Quality Department. This position, reporting to the Senior Director of Audit Operations, involves leading quality initiatives and supporting audit operations. This is an opportunity to get in the ground floor of a rapidly growing company dedicated to protecting patient safety through creating strong supply chain in healthcare and driving the best materials within supply chain.

Responsibilities:

Provide leadership and oversight for all projects associated with the audit platform
Manage interactions and relationships with audit vendors, including conducting post-audit

surveys to ensure industry standards are met

Support membership development and engagement initiatives as needed
Organize SOPs, training manuals, and work instructions in collaboration with internal stakeholders
May take ownership of selected member-based working groups relevant to this role
Role involves triaging audit inquiries to ensure stakeholder expectations are met and providing leadership support to the audit and process teams.

Requirements and Expectations:

A 4-year degree is required, along with previous experience working for a pharmaceutical manufacturer or bio-pharmaceutical supplier.
Understand single-use system materials, IT/SaaS, raw materials, APIs, excipients, and pharmaceutical packaging. Preference will be given to those with direct experience in these areas.
Experience in a quality role, including managing quality systems, quality records, audit observations, deviations, complaint management, and CAPA, preferably in a pharmaceutical manufacturing setting.
Proven experience interacting with regulations such as but not limited to, CFR 210, 211 and ICH Q7
Supplier Quality Management, including supplier risk management, CAPA management, and quality agreements.
Understanding of pharmaceutical manufacturing, including traditional forms (solid dosage, capsules) and specialized types (lyophilized, parenteral, and biopharmaceutical processes such as fermentation and purification).

Jacobs Management Group, Inc.

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