Manager, Global Quality Compliance Support

United Biosource Corporation

2d•Hybrid

About The Position

As a pharmaceutical support industry leader, UBC is devoted to empowering health solutions for a better tomorrow. We take pride in improving patient outcomes and advancing healthcare. At UBC, we provide services to enhance the entire drug development process and commercialization lifecycle - from clinical trial support to real-world evidence generation. Embark on a rewarding career journey with UBC! Grow your career while making a meaningful impact on the world around you. UBC fosters a culture built on our Core Values of Collaboration, Conscientiousness, Collaboration, Curiosity, Compassion and Consultation. We believe in an inclusive workplace that fosters creativity. If you are seeking a career that will challenge, inspire, and reward you, join us at UBC!

Requirements

Bachelor’s degree required preferably in Life Sciences, Clinical, or Business area of study
2- 3 years quality assurance/compliance/auditing experience within a regulated industry (e.g., pharma, medical device, food).
Extensive knowledge of applicable pharmaceutical/biotechnology regulatory requirements (e.g., ICH, GCP, GxP, FDA/CFR, EMA, MHRA, EU GVP)
Proficient PC knowledge required including Microsoft Office Suite (i.e., Word, Excel, Powerpoint, Outlook), Internet, SharePoint.
Experience in management of the corrective and preventive action (CAPA) lifecycle
Experience in Quality Management Systems maintenance
Experience in management of standard operating procedures (SOPs)/policies
Experience in implementation and management of process improvement
Excellent verbal presentation and written communications skills.
Proven interpersonal and relationship building skills.
Proven skills in planning, analysis, and creative problem solving.
Strong organizational and time management skills.
Always be honest with a high level of integrity.
Communicate effectively and professionally
Manage multiple tasks and competing priorities in accordance with business needs.
Be a team player who motivates and educates other team members.
Work independently.
Be detailed oriented.
Ensure confidentiality and discretion.

Nice To Haves

Previous experience of working at a CRO
Experience hosting regulatory inspections and supporting client audits
Preferably at least 1 year of previous managerial/supervisory experience (i.e., experience managing teams and staff).
Preferred exposure to software application development and maintenance.

Responsibilities

Oversee and manage the controlled documents lifecycle and corresponding test assessments. Ensure compliance with internal policies and procedures and target review cycle frequency including appropriate formatting of SOP documents.
Support SOP review and approval process as deemed appropriate
Oversee and manage training related activities (e.g. SOP table of content, training matrix, training decks, other training documentation)
Oversee and provide assistance with CAPA administrative activities (data entry, effectiveness checks, process improvement, ensure process is managed in compliance with policies and procedures, etc.)
Support and assist with GQC IT systems maintenance and change control (CAPA, electronic Document and Learning Management System, other)
Oversee and manage the Regulatory/Client Audit Support functions including audit scheduling and audit calendar maintenance, meeting coordination/logistics, CDA Requests, Auditor Code of Conduct, Setting up internal trackers and portals, Setting up and providing secure Box access for auditor(s) when required, Quality Compliance documentation review prior to and during audit.
Ensure audit reports and responses are stored as per UBC record retention procedures.
Provide administrative support (i.e., agenda, minutes, metrics) for the Global Quality Compliance department.
Assist in department-related special projects.
Other duties as assigned.