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Sr. Director Of Quality Assurance And Control

Company

Covetrus
Address , Portland
Employment type FULL_TIME
Salary
Expires 2023-09-08
Posted at 8 months ago
Job Description
The Sr. Director is responsible for leading all Quality Assurance & Control functions as part of the Covetrus North America Operations Quality & Regulatory team. This role will work with cross-departmental & business leadership to deliver high quality products in accordance with regulatory & customer requirements using proactive risk mitigation techniques as well as through the deployment of robust processes related to deviation management and process & product validation. The Director of Quality Assurance & Control will also be responsible for the quality development of new products, product changes & enhancements in addition to a Supplier Quality program focused on supplier qualification, surveillance, and performance. All functions will be coupled with continued talent development via the deployment of a best-in-class training program. The Director will provide direction to Pharmacy, In-Clinic, & Manufacturing facilities in areas where performance improvement opportunities are identified & monitor trends at a frequency needed to meet business targets. The role will closely align with corporate Covetrus core values and operational targets while being a major advocate in advancing the quality mindset & culture within the Covetrus North America Operations business.
ESSENTIAL DUTIES AND RESPONSIBILITIES including, but not limited to the following:
Leadership & Accountability
  • Establishes & communicates the strategy for Quality Assurance & Control activities throughout the North America Operations business in alignment with Covetrus Corporate & Organizational goals
  • Collaborates with all internal & external stakeholders on the status of key initiatives & outcomes; solicits feedback and implements opportunities for improvement
  • Ensures timely execution of defined activities with a focus on adherence to all regulatory requirements & accrediting body standards as well as alignment with the implementation of the Organizational Quality Management System (QMS)
  • Utilizes data & information to provide guidance & direction to staff on actions needed to meet business objectives and key performance indicators
  • Communicates the progress of the team via monthly, quarterly, annually report outs inclusive of key metrics, information on drivers to positive & negative trends, remediation actions, & business risks
  • Manages Quality Assurance & Control staff & budget to meet business performance & cost measures
  • Leads the Performance Improvement (PI) Program including oversight of key activities, associated thresholds, and Plans of Correction (where required)
  • Identifies & implements organizational best practices aimed at improving operational efficiency, quality performance, customer/consumer outcomes while reducing cost to the business
  • Advocates within organization to continually improve Quality mindset & culture
  • Provides leadership, coaching & mentorship to team members including identification of professional development opportunities & career advancement paths for staff
  • Supports the justification of existing system/equipment enhancements as well as identification & business case development for capital expenditures related to new systems and technology needed to support the operation & achieves defined quality targets
New Product Introduction/Research & Development
  • Ensures the appropriate troubleshooting of product issues (identified internally & externally) including the identification of root causes, corrective actions and effectiveness measures to support continued business operations; communicates internally on the status of critical issues
  • Oversees the development & execution of the New Product Introduction process including onboarding of new products, validation of product transfers and continued deployment of product unification needed to sustain current business and advance areas of growth
  • Provides direction to ensure the appropriate product/process validation activities are defined & executed for planned & unplanned changes to ensure continuity of business and improved customer outcomes
Supplier Quality
  • Works with operational facilities to resolve supplier related issues impacting customers as well internal operations; communicates outcomes including corrective and preventative actions
  • Leads the execution of a robust Supplier Quality Management program including the development of appropriate tools & metrics necessary for supplier monitoring, surveillance, & qualification/disqualification
  • Collaborates with supply chain teams on strategies necessary to mitigate security of supply issues
  • Provides recommendations for future sources of supply balancing cost, quality and lead times to procure products
  • Provides oversight on the execution and closure of required supplier audits; communicates business risks as a result of audit outcomes
Operations Quality Assurance
  • Provides direction on proven Quality/Lean Manufacturing principles & methodologies for use in proactive risk mitigation within the Operations business focused on Continuous Quality Improvement
  • Supports the execution of deviation management activities including completion of internal non-conformances related to out of specification issues and process deviations as well as external customer complaints, adverse events & recalls as applicable.
  • Ensures appropriate process validation methods & techniques are deployed within the Pharmacy, In-Clinic & Manufacturing sites including, but not limited to batch, compounding, work order record & release in accordance with internal & external requirements & regulations.
Training & Education Programs
  • Identifies, monitors & improves Key Performance Indicators (KPIs) related to training & education programs.
  • Provides oversight on the execution of and compliance related to In-Clinic & Manufacturing site training programs
  • Responsible for the execution of the North America Operations training & education programs including the deployment of Web Based & Instructor led trainings for existing staff as well as the onboarding of new hires
  • Oversees the competency requirements & certification programs for Trainers & Subject Matter Experts administering training within the organization
Product Validation
  • Ensures appropriate execution & oversight related to the validation of materials & products at receiving, in-process & at finished testing including the review & release of records & certificates
  • Provides leadership in the management of product samples to approval internal & external laboratories with proper definition on testing requirements and validation that tests performed meet requirements and are acceptable for product release
  • Aligns within internal stakeholders and establishes the defined frequency for product testing based on industry standards, statistical data & desired sampling plans
  • Collaborates with subject matter experts to ensure proper definition of product & materials requirements and ensures implementation of those requirements are imbedded into production workflows
SUPERVISORY RESPONSIBILITIES
  • Directs functions at Corporate, Business and facility level including Pharmacy, In-Clinic & Manufacturing sites.
  • The role will lead both managers & individual contributors across different functions in Quality Assurance, Supplier Quality, New Product Introduction, Materials & Product Validation & Training
TRAVEL
Business travel is required (less than 40% of the time) as determined to meet business demands.
QUALIFICATIONS:
EDUCATION AND/OR EXPERIENCE
  • Analytical and critical thinking skills to include: software systems, workflows (pharmacy, in-clinic, manufacturing), organizational knowledge including applicable industry requirements.
  • Ability to learn new software applications as needed.
  • Knowledge of Quality Assurance, Quality Control and continuous improvement processes
  • 5+ years industry experience in a highly regulated industry
  • Bachelors’ degree in Biology, Chemistry, Engineering, Pharmacy or a similar life science
CERTIFICATES, LICENSES, REGISTRATIONS
  • Certified Quality Engineer &/or Certified Manager of Quality desired
  • Lean Six Sigma training or Equivalent
  • Certifications related to Quality Management Systems (ISO 9001, AS9100, etc.)
COMPETENCIES (SKILLS AND ABILITIES)
  • Strong communication skills both verbal and written are necessary as well as an ability to deal with everyone from front-line employees to top level executives
  • Strong computer skills: proficient in MS Office Suite
  • Proven leadership, assertiveness, interpersonal and analytical skills proficiency is essential
  • Proven analytical and critical thinking skills
  • Ability to demonstrate initiative, possession of strong organizational skills and attention to detail is critical for success on the job
  • Ability to take direction, provide instruction, and recognize the importance of and timing for reaching out to others to ensure high quality work output/performance
  • Ability to function as part of a team with other team members within the company
  • Strategy Development & Communication
  • Well-developed oral and written communication skills including the ability to write and deliver both informal and formal presentations
  • Ability to work in fast paced environment, with demonstrated ability to multi-task and resolve problems effectively and efficiently
  • Ability to prepare clear, concise documents for general and technical needs
PHYSICAL DEMANDS/WORK ENVIRONMENT
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • Pet friendly environment
  • Extensive computer work
Covetrus is an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.
Jobs that are in Colorado:
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