MT. VERNON SITE QUALITY DIRECTOR(Job Number: 1300378)
This position reports directly to the VP, Quality, Americas (with dotted line to Site GM) with job responsibilities that include but are not limited to:
- Management & leadership of the Quality Unit at the Mt. Vernon, IN manufacturing site that supports all Quality activities. •Develops & maintains partnerships with the Site Leadership (SLT) Team to assure that the drug products manufactured, tested, &/or packaged are in compliance with cGMP & global Health Authority filings.
- Working with the SLT assures that the site is in a state of inspection readiness at all times to assure the successful outcome of global regulatory inspections •Leads efforts to ensure the site operates in compliance within policies & directives & Health Authority/Regulatory regulations & evolving expectations.
- Establish the Quality plan, strategy & objectives for the site
- Inspire transformative thinking & motivate employees to deliver benchmark performance •In conjunction with the SLT, chairs the site Quality Council & participates in regional & global Quality Council to continuously improve the quality & compliance performance profile of the site by periodically reviewing KPIs, share best practices, lessons learned, evolving regulations/expectations & inspection findings. •Works in partnership with Quality Product Leaders to support & achieve Product Strategic Plans.
- Works to support Product Robustness Efforts & other initiatives to improve product quality & compliance.
- Takes & recommends actions to ensure monthly Q Score Cards are issued & results are within targets - Develops & advances action plans as appropriate
- Develops & monitors Quality Performance Metrics; for example, right first time, QC schedule attainment
- Provides oversight & leadership to the QC testing laboratory, which is responsible for all aspects of finished goods & incoming raw material & component inspection & release. Responsibilities include, but are not limited to, ensuring compliance with all company SOPs, Directives, Policies, testing requirements & global regulatory agency guidelines & expectations.
- Assures robust succession plans for critical positions & actively supports & develops talent management processes
- Leads & fosters an environment of continuous improvement in all QA, QC & Compliance functions & systems at the site.
- As a member of the SLT, contributes to & supports overall site goals & initiatives.
- Shares best practices and collaborates across sites and with HQ staff.
- B.S. or B.A. in Natural Science (Chemistry, pharmacy, biology, or a related science).
- Master or advanced degree preferred.
- Min 10 years experience in the pharmaceutical Industry in a Quality, Technical, or Regulatory position or combination.
- Direct experience leading manufacturing sites through health authority inspections.
- Direct experience communicating with FDA District offices (e.g., recall activities, Field Alert communications)
- Direct experience dispositioning drug products.
- Demonstrated leadership experience; able to lead a large organization and work in cross functional teams to investigate and manage quality- related issues.
- Demonstrated ability to make and act on decisions while balancing speed, quality and risk.- Significant knowledge in Drug Product Manufacturing, Quality Assurance, Validation, Quality Control, Regulatory Affairs, and Technology Transfer.
- Ability to think clearly and in a decisive manner; remain calm under adverse conditions.
- In-depth knowledge of quality systems principles and applications.
- Demonstrated ability to work independently or with groups of people/teams in a complex changing environment.
- Excellent oral and written communication skills.
- Ability to work in a matrix environment and build strong relationships by being transparent, reliable and delivering on commitments.
- Ability to provide innovative, compliant ideas or alternatives that create value including seeking new information and external insights.
Job Function: Quality
Primary Location: NA-US-IN-Mt. Vernon
: Tech Op - Indiana Technical Operations
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