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Manager, GQC Support

United Biosource Corporation -
Remote

Apply Now

Job Details

14 days ago

Benefits

Wellness program
Health savings account
Paid holidays
Disability insurance
Health insurance
Dental insurance
Flexible spending account
Tuition reimbursement
Paid time off
Adoption assistance
Employee assistance program
Vision insurance
401(k) matching
Employee discount
Life insurance

Qualifications

Microsoft Excel
Microsoft Outlook
Bachelor's degree

Full Job Description

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 5 years quality assurance/compliance/auditing experience within a GCP environment.
Previous experience of working at a CRO
Experience hosting regulatory inspections and supporting client audits
Must have a minimum of 5 years GCP experience.
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.

#LI-HB1

#LI-REMOTE

Apply Now

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