Manager, Global Quality Compliance Support

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!

Manager Global Quality Compliance (GQC) Support

Brief 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

Specific job duties:

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.

Supervisory Responsibility:

None initially. May be a requirement in the future

Desired Skills and Qualifications:

• Bachelor's degree required preferably in Life Sciences, Clinical, or Business area of study with 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. Demonstrated ability to:
• 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.

Benefits:

At UBC, employee growth and well-being are always at the forefront. We offer an extensive range of benefits to ensure that you have everything you need to thrive personally and professionally.

Here are some of the exciting perks UBC offers:

• 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

UBC is proud to be an equal opportunity employer and does not discriminate because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, and basis of disability or any other federal, state, or local protected class. We are committed to a diverse, equitable, and inclusive culture that fosters respect for each other, our clients, and our patients.

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