What You’ll Work On
The incumbent defines and develops strategy for external and internal audits (Regulatory Agencies, Corporate, Notified Bodies, Certifications etc) to ensure that the site is compliant and audit ready at all times.
Acts as a key influential leader, responsible for driving cross-functional audit support and audit readiness initiatives to improve quality systems, and overall organizational compliance to internal/external requirements.
Ensures cross-functional partners and peers understand quality system requirements and how they impact product quality and regulatory compliance.
Represents the site within Abbott through Corporate based community of practice as well as external Regulatory Intelligence Forums.
Utilizes experience and knowledge gained from audits, internal assessments, and cross-business community of practice to proactively address potential compliance gaps.
Responsible for oversight and administration of site’s CAPA system and driving effective resolutions to identified issues.
Responsible for tracking timeliness of change assessments for external requirements and associated metrics.
Lead overall compliance lifecycle or similar programs within the site, collaborates with cross functional leadership, establishes effectiveness criteria, and advises Executive Management on the overall compliance status and audit readiness.
Responsibilities
Provide leadership to maintain Quality Management System compliance for Abbott Heart Failure Atlanta.
Oversee site’s compliance lifecycle, CAPA System and External Requirements Management System.
Lead site’s CAPA program and drive continuous improvements by providing strategic direction for robust CAPA investigations and implementation of global resolutions while ensuring sustainability and effectivity.
Manage External Requirements change impact assessment metrics and ensure changes to regulations, standards, Abbott policies etc are implemented timely.
Serve as the primary interface with external regulatory bodies, manage internal and external inspections and overall audit strategies including any required responses concerning the site.
Provide influential partnership to peers and strategic leadership to other functions within the site to define and implement an effective audit readiness program.
Drive key readiness initiatives utilizing risk-based prioritization and mitigation to maintain an audit ready status.
Evaluate and monitor the results of external and internal audits. Report the audit results to management and status/execution of corrective actions associated with the audit results.
Analyze trends from various sources and proactively address regulatory, compliance, and quality issues.
Actively participate in FDA inspections and lead internal/corporate audits, notified body audits and applicable external certification audits including any post-audit responses.
Provide support for assessment of published regulatory guidance, changes to standards and Abbott policies to determine their impact and implement risk mitigation strategies at site or site level as applicable.
Maintain an understanding of the business climate and relationships while implementing compliance improvement initiatives. Maintain quality excellence in all activities
Maintain data analysis requirements for applicable Quality System metrics and Quality Management Reviews (QMRs).
Lead, guide and retain a diverse, highly qualified staff and provide ongoing performance feedback. Set goals which align to business plans and manage the execution of goals through coaching and mentoring. Maintains a safe, enthusiastic, and professional work environment.
Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
Required Qualifications
Bachelor’s degree in related field
Eight (8) years of Quality Systems, Quality Assurance and/or Regulatory Compliance/Affairs experience in medical device manufacturing or other similarly regulated environment.
Required knowledge of regulations and standards including MDD, MDSAP, MDR, NMPA, applicable U.S. Code of Federal Regulations (CFR 803, 806, and 820), and ISO 13485 and 14971.
Five (5) years in management capacity.
Preferred Qualifications
Prior experience in interfacing with Regulatory and Notified Bodies
Hands-on experience with CAPAs
Understands applicability of Quality System Regulations
Excellent communication, leadership, and analytical skills
Detail-oriented with a strong focus on regulatory compliance.
Ability to work independently and as part of a team.
Strong problem-solving and decision-making abilities.
Proactive and able to manage multiple projects simultaneously.
Apply Now
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott, and on Twitter @AbbottNews.
- The base pay for this position is
- $113,300.00 – $226,700.00
- In specific locations, the pay range may vary from the range posted.
JOB FAMILY
Operations Quality
DIVISION
HF Heart Failure
LOCATION
United States > Atlanta : 387 Technology Circle NW Suite 500
ADDITIONAL LOCATIONS
WORK SHIFT
Standard
TRAVEL
Yes, 10 % of the Time
MEDICAL SURVEILLANCE
No
SIGNIFICANT WORK ACTIVITIES
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf
EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf
