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Global Quality Lead - Program Management Office

Company: PCI Pharma Services
Location: Bedford
Posted on: September 22, 2022

Job Description:

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.We are PCI. -Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.The Quality Leader, Global PMO is responsible for overseeing all Quality related matters related to assigned large capital and customer funded projects across PCI's global network. -This includes all Quality related matters relating to the design/build, qualification and operationalizing the Capital Expansion for assigned programs. -This individual will participate in the development and execution of project timelines and collaborate in developing processes and methods to introduce new facilities, new equipment, and qualification and commissioning work to ensure projects meet committed timelines and customer launch schedules. -The GPMO Quality Leader will work across PCI's matrixed network as well as utilize third party expertise to ensure best practices are developed and followed to execute these critical projects and ensuring launch excellence.Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.

  • Provide QA oversight in the development, construction and deployment of protocols, procedures and policies relating to assigned programs and capital expansion projects managed by the GPMO.
  • Review and approve all commissioning, qualifications and procedures related to the GPMO capital expansion programs in line with internal processes and procedures that exist within site specific and global Quality Systems. -PMO Quality Lead will need to be suitably trained on local SOP's as well as global corporate Quality policies. Innovate and improve existing procedures where needed to meet project goals and objectives.
  • For PCI GPMO programs, this individual assures that systems are in place in all areas of technical operations to achieve compliance with cGMP, EU and global GMP regulations as well as corporate Quality standards. -
  • Works closely with partner GPMO leaders and site Quality representatives on project teams to ensure -all assigned programs and their workstream projects are executed safely, on time, and within budget using Key Performance Indicators to measure performance and keep projects on track.
  • Develop and deliver regular updates to PMO steering committee and ELT as requested.
  • Responsible for all Quality aspects of key capital and customer funded projects across the three PCI Segments.
  • Third party resources will be used when internal expertise does not exist or when workload exceeds team's capacity.
  • Implement and train on project management principles, practices, methodologies, tools, systems, and governance
  • Use good project management tools (e.g. FMEA) to minimize and mitigate risks and proactively identify issues before they arise and develop timely corrective actions as appropriate.
  • Provides coaching, mentoring and development to each Quality team member in both the execution of their group responsibilities and in their own development.
  • Works with GPMO leaders and site team to deliver overall corporate, segment, and site growth objectives in an accountable & collaborative way.
  • Supports a strong culture of Lean and Continuous Improvement for the PMO.
  • Work closely with Engineering, Manufacturing, EH&S and Sales and Project Management to ensure internal and external clients' requirements are met.
  • Correctly employ industry best practices that will successfully withstand inspections by regulatory authorities.
  • Furthers PCI's Environmental, Social and Governance culture and program
  • Will be a subject matter expert for internal, client, and regulatory agencies.
  • Performs other duties as assigned by Manager.Required:
    • Bachelor's Degree in engineering or a scientific field and/or 10-15 years related experience and/or training.
    • Requires a solid knowledge of CFR 210 and 211, 820, GxP's, EU GMPs with particular focus on Annex 1, ICH Q8, Q9 and Q10 and experience dealing directly with regulatory agencies. Background with EU/ICH/PICs regulations is highly desirable. -Comprehensive understanding of the regulations and the ability to interpret and enforce regulatory requirements
    • Previous experience with qualification and validation of aseptic facilities is critical to this role.
    • Must have a demonstrable record of implementing and maintaining total quality system; laying out a strategic plan and overseeing the tactical implementation, driving improved operational and quality metrics. -This person will assure that systems are in place and that inter- and intradepartmental communications are such that "things be done only once - the right way." -
    • Pharmaceutical or Life Science experience
    • Significant experience managing projects, programs, and cross-functional teams -
    • Ability to set and achieve challenging goals.
    • Ability to effectively present information to various stakeholders as the job requires.
    • Familiar with lean and six sigma
    • Ability to prioritize multiple ongoing projects and activities to meet customer and company timelines
    • Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
    • Location requirement: Remote -
    • Travel will be required - 40%Preferred:
      • Master's Degree (M.A.) in related field and/or 10+ years related experience or training.
      • Contract Manufacturing experience preferred
      • A high energy level matched with enthusiasm is an important attitude within the organization and this quality is expected.Join us and be part of building the bridge between life changing therapies and patients. Equal Employment Opportunity (EEO) Statement:PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

Keywords: PCI Pharma Services, Bedford , Global Quality Lead - Program Management Office, Administration, Clerical , Bedford, Texas

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