Quality Compliance Auditor

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 Respect, Accountability, Innovation, Quality, Integrity, and Collaboration. 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!

Job Title: YPC01H - Senior Quality Compliance Auditor

Brief Description: Acts in a Lead role within the Company Quality Compliance department to ensure Quality Management System and requirements goals are met. Responsible for ensuring the Company's quality systems and procedures meet US and international regulatory requirements (e.g., FDA/CRF, GxP, EMA, HRA, EU GVP, GCP) as applicable for business. Performs all appropriate Quality Compliance tasks including hosting/supporting regulatory/client audits and performing internal, REMS, third-party supplier, and investigator site audits. Responsible for writing audit reports, audit responses, and performing appropriate follow-up to completion. Provides assistance and mentorship to other department members as needed. Leads department initiatives, monitors quality metrics, and participates in the Quality Management Council. Facilitates CAPA program, ensures CAPA effectiveness evaluations are performed within a timely manner, performs document review, and ensures Company policies and Standard Operating Procedures (SOPs) are updated within required timelines. Performs other work, as appropriate. Travel as needed, expected 15-20%.

Specific job duties:

• Leads development of annual audit plan(s) for Company and clients, where appropriate.

• Hosts and supports client and regulatory audits. Facilitates development and/or writes audit responses and associated CAPA plans. Ensures CAPA plans are completed as required.

• Conducts internal, third-party supplier, REMS, and investigator site audits. Prepares audit report and tracks follow-up actions.

• Conducts quality compliance document review for the Company and its programs.

• Acts as Lead with department process improvement initiatives and training.

• Participates in and supports Quality Management Council.

• Facilitates Root Cause Analysis (RCA) and completion of CAPA documentation.

• Performs CAPA effectiveness evaluations within a timely manner.

• Acts as a primary Compliance point of contact to support clients directly or indirectly via individual programs.

• Supports and/or conducts review of project-related and application validation documentation, as appropriate.

• Provides assistance and mentoring to other department members.

• Identifies, evaluates and addresses quality issues.

• Assists with development and maintenance of standard operating procedures.

• Performs quality review of project deliverables.

• Performs other quality-related activities as needed/assigned.

Supervisory Responsibility: N/A

Desired Skills and Qualifications:

• Bachelor's Degree or equivalent experience, preferably in Life Sciences, Clinical or Business area of study.

• 3 - 6 years quality assurance and auditing experience in regulated industry (e.g. pharma, medical device, food).

• Proficient PC knowledge required including Microsoft Office Suite (i.e., Word, Excel, Powerpoint, Outlook), Internet, SharePoint.

• Excellent verbal presentation and written communications skills.

• Proven skills in:

• Planning, analysis and creative problem solving.

• Interpersonal relationship building.

• Demonstrated ability to:

• Always be honest with a high level of integrity.

• Communicate effectively and professionally across all levels of the organization, with clients/sponsors, and with regulatory auditors.

• Manage multiple tasks and competing priorities in accordance with business needs.

• Relate to all levels of the user community.

• Be a team player who motivates and educates other team members.

• Work independently under limited supervision.

• Plan, implement and support systems in a complex environment.

• Translate technical language to lay audiences.

• Be detailed oriented.

• Ensure confidentiality and discretion.

• Strong working knowledge of applicable regulations and quality best practices.

• Continual attention to detail in composing, typing and proofing materials, establishing priorities and meeting deadlines.

• Ability lead a project from initiation through completion.

• Ability to lead, mentor, and support teams.

• Knowledge of using teleconference and videoconference programs (i.e., WebEx, Microsoft Teams, Skype).

• Previous audit experience in conducting and hosting internal, vendor, client, and regulatory audits.

• Previous experience with Corrective Action Preventive Action (CAPA) documentation including Root Cause Analysis, Action Plan Development, and CAPA Effectiveness Assessments.

• Working knowledge of applicable regulations and quality best practices.

• Previous experience with client and/or project management.

• Preferred certification, Certified Quality Auditor (CQA).

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:

• Remote opportunities

• 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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