Quality Director, Env Ctrl & Aseptic Compliance

The Quality Director, Env Ctrl & Aseptic Compliance is responsible for environmental monitoring, contamination control, microbiology lab method compliance, media fill unit evaluation, manufacturing aseptic oversight, product tests are meeting internal and external quality and regulatory standards and GMP compliance documentation. The Director has oversight of the site Contamination Control Program, EM Laboratory, and EM investigations.

This position will be a member of the Site Quality leadership Team (QLT) and will report to the Site Quality Operations Leader (SQOL).

What You Will Achieve

• Responsible for providing leadership, strategic direction, and oversight for the different teams
• Responsible for staffing, training & development, motivation & coaching, giving feedback and effective listening & communication towards his/her colleagues.
• Responsible for the environment and the health and safety of the team.
• Plan departmental objectives in support of the site and the PGS objectives
• Ensure that tests are performed according to company and legal standards and methods and are in full compliance with cGMP’s.
• Stay current of internal and external requirements and regulations and keep focus on best practices
• Manage department at optimal overall cost
• Provide lab support for site projects and registration
• To promote and ensure a high level of GMP awareness and culture in the labs
• Ensure that all personnel are adequately trained and developed as needed
• Foster an environment of continuous improvement and learning in Quality, GMP, equipment, methods, processes
• Drive / support operational excellence through:
  • Data driven analysis
  • Compliant, effective, and efficient systems
  • Continuous improvement principles and tools
  • Use of standard work processes
  • Effective teamwork and organization in general
  • Trend analysis of deviations and defining /follow up of preventive actions
  • Provide vision to support process owners
• Ensure individual and team training is up to date relative to the duties being performed.
• Responsible for staff development of direct reports and others.
• Sets expectations for goal setting, ongoing assessments, and coaching/performance evaluations to motivate direct reports and deliver results for the department and business lines.
• Identify growth and development opportunities for direct reports.
• Respects the PGS vision, mission, values and leadership behaviors in order to realize the PGS objectives related to quality, GMP, customer satisfaction, right first time and cost.

Here Is What You Need (Minimum Requirements)

• Must have a Bachelor’s Degree in relevant scientific discipline, microbiology, chemistry, pharmaceutical sciences or engineering with 8+ years relevant experience in the pharmaceutical industry,
• OR MBA/Master's Degree with 7+ years relevant experience in the pharmaceutical industry. 
• 5+ years of management experience 
• Analytical and scientific skills 
• Proven problem-solving abilities 
• Organizational skills 
• Good human interaction and leadership skills with different levels in the organization (negotiating, convincing, motivating, coaching, listening, learning)
• Good communication skills (oral and written) 
• People Leadership (leader of leaders) and talent development experience. 
• In-depth knowledge and experience of pharmaceutical cGMP, principles and concepts of relevant quality processes based on previous roles. 
• Ability to function autonomously in a matrix model and in a team environment. 
• Able to communicate complex information in both verbal and written formats. 
• Good interpersonal and leadership skills including a demonstrated ability to positively influence and coach others. 
• Sound knowledge of current Good Manufacturing Practices and the applicable GxP regulations and standards. 
• Sound knowledge of validation principles and methods, quality by design.  
• Experience with GMP electronic systems and tools
• Ability to work independently as well as in a team environment within own team and interdepartmental/matrixed teams. 
• Proactive approach and strong critical thinking skills. 
• Effective written and oral communication skills. 
• Self-motivated, engaged, and able to perform moderately complex tasks independently. 
• Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

PHYSICAL/MENTAL REQUIREMENTS

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