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Director, Quality Systems

Company: Disability Solutions
Location: Severn
Posted on: April 2, 2024

Job Description:

POSITION SUMMARY The Director, Quality Systems is responsible for the management and oversight of the core quality systems, including investigation/deviation management, CAPA tracking, change control, risk management, supplier quality, audits and inspections, raw materials release, and compiling, trending and reporting key quality metrics for Senior Management review, and other quality system functions, as needed.The Role

  • Provides strategic direction to the QA Systems staff supporting Investigation/Deviation/ CAPA Management, Change Control, Risk Management, Quality Metric Tracking responsibilities
  • Ensure staff are fully trained on all cGMP manufacturing operations and documentation and adhering to safety guidelines----
  • Build effective teams that apply their diverse skills and perspectives to achieve common goals. Drive engagement and create a culture where employees are motivated to do their best
  • Oversee daily activity for the group to ensure quality results Performance management for direct reports.
  • Responsible for and administers Investigation and Deviation systems for tracking statuses, follow-up, and liaison with applicable department investigation writers to ensure their complete and timely resolution
  • Responsible for and administers the CAPA Tracking System for general GMP use and internal audits. Track the timely completion and extension of commitments
  • Perform trending reviews of deviations and investigations, compile reports and identify trends or areas requiring additional actions
  • Responsible for and administers the change control system for tracking and coordinating the initiation, execution and completion of change controls
  • Responsible for and administers the Risk management system and track completion of risk assessments
  • Compile pertinent QA metrics for Senior Management review
  • Assemble critical metrics from applicable departments, analyze using appropriate tools to identify trends and report via a PowerPoint presentation to be reviewed by Senior Management on a periodic basis. Track action items for completion
  • Support client projects and provide quality oversight of manufacturing operations and the release of drug substance and/or final drug product to support Phase I/II clinical trials
  • Work with clients during initial and subsequent manufacturing campaigns
  • Maintain databases and systems used for tracking various GMP manufacturing associated support activities
  • Assists with the generation and/or revision of GMP documentation such as standard operating procedures
  • Manages regulatory (FDA, EMA) and client audits/inspections of Catalent. Responsible --performing internal audits
  • Work closely with other departments at Catalent and offer assistance as needed
  • Continually evaluate systems and procedures for improvement for efficiency while ensuring compliance to applicable regulatory requirements and standardsThe Candidate
    • Bachelor's degree with 12-14 years or Masters' degree with 10-12 years in a Scientific, Engineering or Biotech field within the biologic, pharmaceutical or medical device industry performing direct hands-on work in a Quality Assurance/Quality Control function with a strong familiarity of general GMP documentation.
    • 6 - 8 Progressive Leadership experience, experience with Performance Management, Goal Setting and Managing through Conflict.--
    • ASQ CQA (American Society of Quality Certified Quality Auditor) highly desirable
    • Have the knowledge, and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality tasks
    • Experience with Good Manufacturing Practices (GMPs) and 21 CFR Parts 210 and 211 OR Quality System regulations (QSR) per 21 CFR Part 820
    • Expert knowledge of biological regulations (21 CFR Part 600s) or EU GPs, a plus
    • Proficient with electronic systems, including developing and producing reports.
    • Experience with data analytics and concepts
    • Ability to quickly learn and navigate new electronic systems
    • Able to work in a team setting and independently under minimum supervision
    • Ability to work in fast paced environment supporting the quality assurance/quality control departments of a CMO for Phase I/II/III GMP manufacturing of biologic bulk drug substance and sterile finished drug product.
    • Creative individual with excellent trouble shooting skills
    • Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience.Why You Should Join Catalent
      • Defined career path and annual performance review and feedback process--
      • Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives--
      • Dynamic, fast-paced work environment
      • Generous 401K match and Paid Time Off accrual--
      • Medical, dental and vision benefits effective day one of employment--
      • Tuition Reimbursement--
      • GymPass program to promote overall physical wellness--
      • Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categoriesCatalent offers rewarding opportunities to further your career!-- Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.--Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone's safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.------personal initiative. dynamic pace. meaningful work.Visit to explore career opportunities.Catalent is an Equal Opportunity Employer, including disability and veterans.If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.--------Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.Important Security Notice to U.S. Job Seekers:Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.California Job Seekers can find our California Job Applicant Notice .

Keywords: Disability Solutions, Severn , Director, Quality Systems, Executive , Severn, Maryland

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