Position Title: Quality Auditor - III
Work Location: Remote (Up to 20% travel may be required)
Assignment Duration: 11+ months

Description:

The Global External Quality Operations Mission is “to be a proactive partner, driving a science and risk-based compliant quality culture that is flexible, innovative, and customer oriented, maximizing the contribution of Quality Operations to Our Path Forward initiatives.” ?
External Supply Operations Quality (ESOQ) is committed to supporting Client Global Supply (PGS) as an innovative and competitive advantage for Client by assuring the quality of products manufactured and packaged by other companies (Contractors) for Client.
ESOQ is responsible for the Quality & Regulatory management of approximately 300 contract manufacturers, packagers, and supply partners globally.

Responsibilities:

• The ESOQ Manager holds overall accountability for assigned CMOs, with primary responsibility for quality oversight (approximately 80%) and secondary responsibility for regulatory oversight (approximately 20%) across operational activities.
• The ESOQ Manager is accountable for providing quality assurance management of key contractors for Client and for assuring that the products supplied to our patients are manufactured & tested in accordance with c-GMPs, the registration file and any additional country specific requirements.
• This is highly independent position operating with minimal supervision, interacting with high levels of management both at contract manufacturers and within Client.
• (S)he will operate as spokesperson for ESOQ and will focus on developing relationships, independently negotiating, developing and communicating Client quality requirements with contract manufacturers.?
• ESOQ Manager will have significant interactions with many internal business and manufacturing organizations (e.g. External Supply, Regulatory, Technical Support, Quality, PGS sites and R&D) and will lead virtual cross functional teams.
• Initiate, review and approve regulatory changes through Client enterprise system (i.e. PDM) for changes initiated by or impacting ESOQ managed contractors.
• Provide support for the closure of the deficiency letters, CMC Commitments, Regulatory requests for Renewals, New Product Registrations and Post approval variations.
• Main point of contact for Global Chemistry, Manufacturing & Controls (CMC) or Local Regulatory Affairs in Client Country Offices (Single market prods) for the regulatory activities involving the ESOQ contractors.
• As the Quality & Regulatory Expert, participate in Virtual Site Operating Teams (VSOT) for ESOQ managed contractors and if needed, participate in Site Quality visits at the contractors.
• Support and Perform Lot Disposition for Biotech semi-finished and finished products (if applicable).

Qualifications:

• Minimally BA/BS Science, Engineering, or related technical discipline with at least 7 years in a GXP setting and/or Regulatory Affairs role
• At least 4 years of Product Quality Assurance experience in a GMP environment with Aseptic manufacturing experience.
• Advanced computer skills, MS Office and enterprise systems such as SAP, QTS, PDM, Documentum platforms
• Command of English language required and multi-lingual is a benefit
• Strong verbal and written communication including presentation skills
• Shows strong negotiation skills and is diplomatic in communication with internal and external customers
• Demonstrated ability to manage multiple projects and priorities
• Demonstrated ability to prioritize work, to act and work independently and to escalate items as required to Team leader
• Demonstrated excellent organization skills
• Demonstrated experience managing complex quality and compliance activities in a manufacturing plant or with a contractor
• Developing personal leadership to manage cross functional projects
• Developing ability to resolve conflicts
• Takes initiatives and is proactive, persistent
• Has a broad GMP and technical know-how to handle emerging issues
• Able to report remotely and deliver work independently

 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 60.88/daily.