- Develop and maintain Product Quality Review Management with Sarepta cross functional areas and vendors for annual data trending to allow issue resolution and process improvements including re-evaluation of product/ material specifications while driving closure within 90 days after reporting period and maintenance of up-to date/ accurate QTAs
- Responsible for triage/communication for significant events to Sr. Leadership, tracking, management, and completion of cross functional areas Quality Records (such as deviations, lab investigations, change control, and CAPA) in partnership with applicable SMEs. Leads error prevention and continuous improvement initiatives based on identified recurring root cause and implementation of effective CAPA.
- Serves as the Quality Record (PR) Subject Matter Expert (SME) for the designated departments. e.g., Quality Control team
- Leads complex technical investigations independently with occasional guidance and support
- Drives closure of Quality Records by completing records per defined Standard Operating Procedures (SOPs) or by providing coaching and mentoring to record Authors and Contributors
- Reviews and approves records for quality and consistency to ensure Right-First-Time approval by Quality Assurance and on-time closure of records.
- Monitors, analyzes, and reports on quality record trends for the functional area to reduce non-conformance occurrences and recurrence over time
- Utilizes quality record data trends, cGMP knowledge and Lean Six Sigma philosophy (i.e., Gemba Walk, 5 Why's, Pareto Analysis) to actively identify, drive and implement continuous improvement / error prevention initiatives within the functional area
- Provides training on Root Cause Analysis to record Authors and Contributors as necessary.
- Works on or leads other projects related to Error Prevent in response to identified CAPA.
- Develop and execute training qualification program for lead investigators to develop proficiency and knowledge commensurate with complexity of investigation level of minor, major, or critical
- Proactively identify current and future risk participating in internal Sarepta inspections and develop integrated action plans to mitigate and remediate adverse impact
- Develop and maintain process for GxP quality management system SOPs and processes to identify potential gaps to Sarepta GxP and Corporate Policies for risk mitigation and remediation as appropriate
- Review and approve QMS record management to ensure timeliness, complete documentation, compliance, and effectiveness to SOPs
- Continue to improve on process to identify and resolve issues as part of QMS and Compliance Metric Program including monthly updates to cross functional QMS owners in preparation for quarterly Quality Review Board
- Perform Quality technical review for change control submissions
- Support Regulatory Inspections and regulatory submissions
- Participate in special projects as assigned
- B.S. or B.A. degree (preferably in Life Science, Health Science or Biology) and five to ten years relevant experience in the pharmaceutical or biopharmaceutical industry (e.g., biologics) background and quality assurance (minimum of 5-10 years)
- Quality professional with 5+ years of hands-on experience with increasing responsibility in a QA and/or Quality Engineering function
- Strong Project Management skills/ experience
- Proficient in tracking and trending metrics for purposes of continuous improvement of processes and procedures
- Ability to perform statistical analysis
- Highly motivated, strategic individual with compliance, quality assurance, and healthcare management expertise
- Ability to increase personal responsibility whilst focusing on the empowerment and development of others
- Strong interest to develop strategic process improvement plans to maintain operational excellence
- Excellent leadership and management skills
- Significant GMP experience in either clinical and/ or commercial products, global experience
- Acquired knowledge of US GxP compliance regulations and industry practices, as well as EU GMP requirements
- Acquired knowledge of GMP Quality Management System (QMS) oversight for compliance
- Excellent communication and organizational skills, as well as negotiation, influencing, and collaboration skills, and demonstrated ability to work cross functionally across internal stakeholders
- Proficient in building consensus, negotiating, and escalating issues and risk management
- US FDA/EU inspection experience (participating or leading)
- Demonstrated continues improvement experience (i.e., six sigma certification)
- Excellent communication skills verbally and in writing
- Ability to handle high pressure environment associated with meeting deadlines
- Independent: able to work with minimal supervision; demonstrate initiative and self-direction
- Ability to manage multiple concurrent projects and to deliver results accurately and on time
- Strong interpersonal skills including teamwork, listening, giving feedback, giving instructions, and conflict resolution
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Manager QA Compliance, Quality Engineer - Andover, United States - Sarepta Therapeutics
Description
The Sarepta Therapeutics QA Compliance Unit is seeking to fill a Full-Time position for Manager, Quality Engineer to develop and maintain GxP quality systems processes and procedures to drive quality compliance and business efficiencies. Develop and maintain processes to facilitate QMS record completion through overseeing and enabling proper investigation including problem understanding, true root cause identification and effective CAPA to prevent reoccurrence. This position will work cross functionally with quality assurance operations, quality control, manufacturing, validation, Manufacturing Science &Technology (MS&T) and external vendors to gather, analyze and interpret and report data from product manufacturing and testing as part of trending programs (e.g., Product Quality Review, Quality Event Trending, clinical manufacturing in process and release/ stability data, laboratory controls data) to address adverse trends/ gaps as part of continuous improvement. This position will be responsible for tracking, management, and completion of cross functional area Quality Records (such as deviations, lab investigations, change control, and CAPA) in partnership with applicable SMEs and leads error prevention and continuous improvement initiatives based on identified recurring root cause.
Primary responsibilities include:
This position is hybrid, you will be expected to work on site at one of Sarepta's facilities in the United States and/or attend Company-sponsored in-person events from time to time.
The targeted salary range for this position is $112,000 - $140,000 per year. Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Sarepta's compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity.
Candidates must be authorized to work in the U.S.
Sarepta Therapeutics offers a competitive compensation and benefit package.
Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.
