Job description
At BioAgilytix, we are passionate about premier science and the impact it has on our world. Our team of highly experienced scientists and professionals deliver tailored services for supporting new medicine breakthroughs with best-in-class bioanalytical services. We are tirelessly committed to our customers by being solution-oriented and deadline-driven. . . and we are growing. Our culture is fast-paced, fun and never boring. Because we work across numerous clients and drug modalities, your career can develop rapidly. You’ll gain experience with a variety of challenges all while you enable life-changing, life-saving therapeutics to the patients who need them.
The Corporate Compliance Manager (Vendor Quality) is responsible for providing quality assurance (QA) oversight within the Quality Management System (QMS). He or she ensures Corporate and vendor-provided GxP activities are compliant with national/international GxPs. The Corporate Compliance Manager may also be responsible for leading and managing a team that supports the BioAgilytix (BAL) QMS.
Essential Responsibilities
- Manages BAL Vendor Assessment and oversight and addresses quality and compliance issues associated with outside vendors and contractors
- Provides quality guidance in the development and revision of quality procedures, policies, and plans in support of a QMS function
- Assures Corporate and vendor-provided GxP activities related to BAL operations follow national/international GxPs
- Performs QA review and approval, and ensures timely closure of document change controls, deviations, CAPAs, and investigations as related to vendor activities
- Represents the QMS and vendor oversight function during Regulatory inspections/Sponsor audits
- Maintains records, schedules, and lists as appropriate for the vendor management function
Vendor Quality Management Lead:
- Works closely with BAL colleagues and QA Senior Management, monitoring and providing support for vendor identification, risk classification, selection, audit, issue escalation and investigation, regulatory needs, and metrics to ensure quality standards are met, with little supervision
- Leads, schedules, performs, or oversees the use of contractors to perform and report audits of critical vendors as per the relevant SOPs
- Communicates with vendors to issue audit observations, collects and tracks responses and corrective actions from vendor audits within required time to ensure up to date information is always available
- Assists with preparation, review and approval of corrective action plans as needed
- Establishes and monitors metrics for trends relating to vendor audits and performance
- May assist in other Quality projects, including but not limited to: Performing data audits, internal audits; providing training related to regulatory affairs and QMS systems
Additional Responsibilities
- Other duties as assigned
Minimum Preferred Qualifications
Education/Experience:
- Bachelor's degree in biology, chemistry, other scientific or related discipline
- Not less than five(5) years of experience in pharmaceutical, CRO/CMO or similar organization
Skills:
- Strong, working knowledge of GxP regulations
- Demonstrated project coordination and management skills; strong experience in a QMS function
- Abilitytoworkinafast-pacedteamenvironmentwheremultipleconcurrentprojectsmustbe completed in a timely manner
- Ability to take direction and self-motivate with strong work ethic
- Acute attention to detail
- Strong organizational skills that reflect the ability to perform and prioritize multiple tasks seamlessly
- Excellent written and verbal communication skills; ability to communicate concepts to multiple audiences via different means of communication (e.g., face-to-face, email, phone)
- Demonstrated proficiency in Microsoft Office (Word, Excel, Outlook, etc.)
Supervisory Responsibility
- Corporate Compliance Assistant
- Corporate Compliance Specialist I
- Corporate Compliance Specialist II
Supervision Received
- Infrequent supervision and instructions
- Frequently exercises discretionary authority
Working Environment
- Primarily office (i.e., blend of office and work from home)
- Routinely uses standard office equipment such as computers, phones, photocopiers, and filing cabinets
- Occasional travel required
Physical Demands
- Ability to work in an upright and/or stationary position for up to eight (8) hours per day
- Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists to operate office equipment
- Occasional mobility needed
- Occasional crouching, stooping, with frequent bending and twisting of upper body and neck
- Light to moderate lifting and carrying (or otherwise moving) objects, including files and a laptop computer, with a maximum lift of 20 pounds
- Ability to access and use a variety of computer software
- Ability to communicate information and ideas so others will understand, with the ability to listen to and understand information and ideas presented through spoken words and sentences.
- Frequently interacts with others to obtain or relate information to diverse groups
- Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals; requires multiple periods of intense concentration
- Performsawiderangeofvariabletasksasdictatedbyvariabledemandsandchanging conditions with little predictability as to the occurrence
- Ability to perform under stress and multi-task
- Regular and consistent attendance
Position Type and Expected Hours of Work
- This is a full-time position
- Some flexibility in hours is allowed, but the employee must be available during the “core” work hours as published in the BioAgilytix Employee Handbook
- Occasional weekend, holiday, and evening work required
- Occasional travel required
BENEFITS AND OTHER PERKS
Medical Insurance (HDHP with HSA; PPO), Dental Insurance, Vision Insurance, Flexible Spending Account (medical; dependent care), Short Term Disability \u007C Long Term Disability Life Insurance, Paid Time Off (4 weeks per year), Parental Leave, Paid Holidays (10 scheduled; 3 floating), 401k with Employer Match, Employee Referral Program
COMMITMENT TO EQUAL OPPORTUNITY
BioAgilytix provides equal employment opportunities to all employees and applicants for employment without regard to race, color, ancestry, national origin, gender, sexual orientation, marital status, religion, age, disability, gender identity, results of genetic testing, service in the military, or any other group protected by federal, state, or local law.
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