[Hiring] Manager, Global Quality Compliance Support @United Biosource Corporation

Role Description

The Manager Global Quality Compliance (GQC) Support oversees and manages the core support functions for the Quality Management System (QMS) set up and maintained by the Global Quality Compliance department including controlled documents management, training management, and continuous improvement (CAPA, audit). Audit support includes, but is not limited to, audit scheduling, logistics, and document preparation and support. There will be some travel for face-to-face inspections.

• 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.
• 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.

Qualifications

• 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).
• Previous experience of working at a CRO.
• Experience hosting regulatory inspections and supporting client audits.
• Extensive knowledge of applicable pharmaceutical/biotechnology regulatory requirements (e.g., ICH, GCP, GxP, FDA/CFR, EMA, MHRA, EU GVP).
• Preferably at least 1 year of previous managerial/supervisory experience (i.e., experience managing teams and/or staff).
• 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.
• Preferred exposure to software application development and maintenance.

Requirements

• 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 detail-oriented.
• Ensure confidentiality and discretion.

Benefits

• Competitive salaries.
• Growth opportunities for promotion.
• 401K with company match.
• Tuition reimbursement.
• Flexible work environment.
• Discretionary PTO (Paid Time Off).
• Paid Holidays.
• Employee assistance programs.
• Medical, Dental, and vision coverage.
• HSA/FSA.
• Telemedicine (Virtual doctor appointments).
• Wellness program.
• Adoption assistance.
• Short term disability.
• Long term disability.
• Life insurance.
• Discount programs.