Associate 2/Sr. Associate, QA CMO
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.
BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Come join our team and make a meaningful impact on patients’ lives.
This is an individual contributor position in the Quality CMO Core team. The individual is expected to perform routine job functions independently with minimal supervision. The Core group functions to actively support the Quality CMO department (Commercial, Clinical, and Small Molecule groups). The Quality CMO Associate is expected to build relationships and communicate well with QA, QC, Supply Chain, Materials Management, Regulatory, and CMO both at BioMarin and external CMOs.
Detailed responsibilities include but are not limited to the following:
- Review and sign-off on shipment temperature data to issue Certificates of Compliance, Certificates of Compliance for Further Processing, and temperature approvals for timely drug release
- Provide Quality oversight and manage shipment-related deviation and CAPA lifecycles.
- Perform Quality contact duties for temperature related Quality Events, Deviations, Change Requests, and CAPAs.
- Oversee temperature review and temperature excursion SOPs.
- Timely transact approved lots within Oracle EBS.
- Track ID samples through LabWare LIMS, for use in ID and product stability testing.
- Contribute group release data to commercial and clinical lot release trackers.
- Monitor TrackWise PRs (Quality Events, Deviations, Change Requests, and CAPAs) and follow-up with individuals weekly to progress records ensuring timely closures.
- Manage and interpret Quality metrics and provide input based on reports
- Scan, organize, and archive released records for electronic storage on Office365.
- Manage storage and archival of physical batch records.
- Perform gap analysis on Quality Technical Agreements (QTA) and publish/retire finished documents using the internal electronic document management system (EDMS).
- Manage product specification document lifecycle. Create and route product specification documents, following MAA/BLA/CTA/IND/IMPD filings provided by Regulatory Affairs
- Set-up and approve Change Requests records for product specification documents.
- Create manual Certificates of Analysis, as needed.
- Manage and maintain the CMO Scorecard process.
- Assess and investigate issues related to Product Release Controls (PRC) system. Provide timely resolutions to enable lot release.
- Ensure all individual training and group-specific guidelines are kept current.
- Manage and complete assigned projects, as needed
- Assist with regulatory and internal inspections, as needed.
- Collaborative Leadership - Ability to influence with or without authority, facilitate groups with diverse perspectives, bring teams to consensus/alignment. High tolerance for ambiguity and able to create order from chaos. Builds credibility through solid relationships and solid track record of results.
- Ownership and Accountability – Takes accountability for actions, drives results, and able to learn from mistakes. Delivers on promises, goals, and expectations. Makes quality decisions and resolves problems with minimal delay as appropriate. Asks “what can I do to help?”
- Communication - Ability to communicate effectively up and down, at all levels of the organization, present complex and/or new ideas with clarity and simplicity. Ability to draft and deliver clear and concise procedures or business process documents.
- Planning - Excellent planning and prioritization skills with the ability to multitask and adapt. Able to synthesize large amounts of information. Able to deliver results despite shifting environment.
- Analytical Problem Solving – Ability to identify problems, define problem statement clearly and accurately and apply structured and disciplined methodology to identify data-driven root causes. Innovative and effective in solution development, risk mitigation, and execution.
- Customer focus - Partners with customers, looks ahead to predict future customer needs. Manages expectations.
- Minimum 6 years of experience in a Quality/Compliance/Regulatory setting
- Sound knowledge of cGMPs and equivalent industry regulations
- Prior experience with technical oversight of Deviations and CAPAs
- Proficiency with computer systems – Microsoft Office Suite
- Proficiency with TrackWise or QMS, LIMS, Oracle, EDMS, and Office365 preferred
BS in a technical science field
WORK ENVIRONMENT/PHYSICAL DEMANDS
The employee may frequently be required to sit and talk or hear. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and taste or smell. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities by this job include close vision, depth perception and ability to adjust focus.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.