Senior QA Director – GMP

at PPD (view profile)
Location Middleton, WI
Date Posted March 25, 2020
Category BioPharma
Job Type Full-time
Address 3230 Deming Way

Description

Expect more from your career. Expect PPD.

The PPD GMP Laboratories business unit of PPD is a market leader in providing GMP analytical services to the pharmaceutical, biotechnology, and medical device industries. The PPD GMP Laboratories have ~1,400 employees located in Middleton, Wisconsin and Athlone, Ireland. This is an exciting opportunity to join a rapidly growing scientific service business within one of the world’s premier drug development companies.
We provide a full complement of state-of-the-art GMP analytical testing resources and expertise to support commercial stability studies, release testing and quality control analyses for active pharmaceutical ingredients and drug products in virtually all dosage forms and delivery systems.

As the Sr Director (GMP), your basic purpose will be to ensure efficient and effective management of PPD resources. You will supervise and assist group leaders and scientists in laboratory operations with tasks such as scheduling, resource management, technical and compliance related issues. In addition, you will plan, direct and implement improvements in systems, processes and procedures to increase efficiency, productivity and quality in the laboratory. You will assist the division director in strategic planning, business development and expansion initiatives by providing mid-range (1-3 month) resource utilization predictions for a department.

Summary:

Provides strategic direction, leadership and management of a QA department and/or program. Where and when role requires incumbent provides oversight to auditing techniques, interpretation of regulations and guidelines, clinical supplies, computer validation and compliance, and/or therapeutic training. Assists business development and senior management in securing new business. Develops effective solutions, using proven problem solving techniques, to address non-conformance issues with existing clients. Responsible for achieving overall financial goals for department

 

  • Develops and executes GxP compliance strategies and establishes quality and compliance standards and matrices for PPD's clinical research operational units
  • Analyzes compliance/quality matrix data, notifies senior management of critical compliance nonconformance
  • Takes leadership role with peers in operational units to proactively identify issues impacting the quality and/or integrity of clinical research and/or laboratory programs, determines root cause of nonconformance, and develops effective problem solution strategies
  • Provides strategic and tactical direction to staff for assigned department(s) in execution of departmental objectives
  • Hires, develops, and mentors staff to expand organizations capability and ensure effective management of QA staff
  • Manages contracts to ensure contractual obligations and business requirements are met
  • Serves as Senior Advisor to peers, teams, and clients on the interpretation and implementation of current FDA and International GxP and computer validation trends and requirements
  • Assesses impact of client and regulatory observations of data integrity and overall quality management and provides recommendation for corrective action to the respective teams
  • Assists in business development activities to obtain additional contracts by writing and reviewing proposals, making presentations to potential clients and representing the department at appropriate professional meetings and conferences
  • Fosters client relationships and provides strategic guidance on quality business initiatives. Provides regulatory support for clients as needed for addressing regulatory concerns such as validation issues and agency questions as needed
  • Maintains leadership role through active participation in leadership team meetings, presentations to site staff on compliance and quality issues
  • Develops and maintains applicable quality and site metrics. Participates on site quality and business process improvement issues
  • Handles delegated tasks and responsibility as requested by senior leadership. Represents QA at client audits and regulatory authority inspections

 

Qualifications:

Education and Experience:

  • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 15+ years) or equivalent and relevant combination of education, training, & experience.
  • 7+ years of management responsibility
  • Advanced leadership skills

Knowledge, Skills and Abilities:

  • Excellent leadership skills and business acumen
  • Proven financial management and budgeting skills
  • Strong organizational agility with ability to successfully operate in a matrix or team environment
  • across multiple locations, countries and regions
  • Ability to successfully handle multiple responsibilities, priorities and tasks
  • Exceptional oral and written communication skills
  • Demonstrated interpersonal, team building and leadership skills
  • Proven ability in proven problem solving (e.g., Six Sigma, TQM, etc)
  • Thorough knowledge in interpreting and implementing appropriate FDA regulations 21 CFR and guidelines pertaining to GxP with applicable ICH guidelines, European Directives and country specific regulations on clinical research and drug development
  • Ability to manage complex projects on time and within budget
  • Demonstrated ability to lead business and process improvement initiatives

Management Role:

Director role with significantly larger management scope (e.g. global or regional responsibilities or multiple departments) OR mastery of director skills and responsibilities as demonstrated by consistent, multi-year successful performance. Directs through subordinate management. In some instances may be responsible for a functional area (as determined by executive management) and not have subordinate supervisors or employees. May manage employees across multiple regions.

Working Conditions and Environment:

  • Exposure to high pressure, intense concentration needed
  • Must pay constant attention to detail-visual, mental
  • Must be able to multi-task constantly
  • Frequent interaction with clients / associates required
  • Long, varied hours required occasionally
  • Travel and rotating shifts required on rare occasions
  • Exposure to toxic materials on rare occasion

Physical Requirements:

  • Frequently stationary for 6-8 hours per day.
  • Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
  • Moderate mobility required.
  • Occasional crouching, stooping, bending and twisting of upper body and neck.
  • Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
  • Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
  • Ability to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
  • Frequently interacts with others, relates sensitive information to diverse groups both internally & externally.
  • Ability to apply abstract principles to solve complex conceptual issues. Requires multiple periods of intense concentration.
  • Performs a wide range of complex tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.
  • Regular and consistent attendance.
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