BioTel Research is a division of BioTelemetry, Inc., the leading remote medical technology company focused on the delivery of health information to improve quality of life and reduce cost of care. Recognized as an industry pioneer, we are experienced in all phases of clinical trials, across all major therapeutic areas and all global regions. We are experts in medical imaging and cardiac safety, and have the unparalleled capability to test drugs and devices from early research through post-marketing surveillance. We are passionate about connecting people with solutions that save lives, and our growth reflects our focus, commitment and passion for the important work we do each day. As one of the fasted growing connected health companies in the market, we are looking for people to join our team who share our passion and focus.
Quality Assurance Project Manager
Overall Job Summary:
The Quality Assurance Project Manager (QA PM) is responsible for supporting the management and oversight of Corrective and Preventive Action (CAPA) activities in the Quality Assurance and Regulatory Affairs team. These responsibilities include coordinating investigations, writing CAPA plans and the ongoing monitoring of pending actions. Additionally, the QA PM will be responsible for supporting other Quality Assurance and Regulatory Affairs processes as needed, such as audits (internal/external), deviations, letters to file, etc. They will also provide guidance on quality and regulatory compliance requirements as needed. Finally, they may assist with different process improvement initiatives including revising current procedures, cross-departmental discussions, and organizing completion of actions.
Support management of Corrective and Preventive Action (CAPA) activities including logging, conducting investigations, and writing CAPA reports and ongoing monitor activities
Develop and maintain CAPA metrics
Lead and coordinate process improvement initiatives, as needed
Support Deviation, Letter-to-File and Audit (Internal & External) processes
Provide guidance on quality and regulatory compliance related requirements
Work with and assist the Quality Assurance and Regulatory Affairs team, as requested
Assist with special projects, as required
The physical demands are representative of those an employee encounters while performing the essential functions of this job program
Education: BS/BA degree or equivalent experience required.
Relevant Work Experience:
Three or more years of experience working in pharmaceutical, medical device, biopharmaceutical, or equivalent regulated field - required
Experience in driving business results (metrics), managing projects, and facilitating cross functional teams.
Knowledge of QA/RA processes such as CAPA, Deviation, Audits, Documentation Control, etc.
Required Knowledge, Skills, and Abilities:
Knowledge/Abilities -Technical Skills:
General understanding of 21 CFR Part 11 and other FDA regulatory requirements (especially those associated with clinical trials), GCP and ICH guidelines and directives is desired
Ability to work with data spreadsheets, select metrics and identify trends
Highly developed investigational skills
Ability to work in groups and individually with little supervision
Computer literacy and training and experience in Microsoft Office products, required
Communication Skills (Verbal/Written):
Excellent written and verbal communication skills.
Demonstrated ability to communicate effectively and constructively across departments.
Strong leadership skills.
Customer Service: WECARE - BioTelemetry based customer centric program
Ability to initiate and manage multiple tasks.
Ability to work as part of a team, meet deadlines & take instruction from multiple persons.
Extensive experience leading projects to completion.
EEO/AAP - Biotelemetry provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state or federal law.
NOTE: This job description is not intended to cover or contain a complete listing of all duties or responsibilities that are required of the employee. Other duties, responsibilities and activities may change or be assigned at any time with or without notice.