Shire Senior Expert – Process validation in Lexington, Massachusetts

Job Summary

Primary Role

Provide a brief summary describing the major role, responsibilities and purpose of the job. Summarize key areas of accountability and budget responsibility, if applicable.

The QbD Systems Senior Expert is responsible for

  • Support in directing and leading all global & cross-functional activities related to the development, deployment and continuous improvement of Shire´s Process Validation (“QbD”) approach throughout the entire product and process life-cycle with the focus on Stage 1 related risk based methodologies

  • Ownership of specific sub-processes of the global QbD-System including deployment and coaching of executing function across the entire Shire manufacturing network with the focus on Stage 1 related risk based methodologies

Essential Functions

Responsibilities

Describe the essential job duties. After each, provide an estimate of the percent of time typically devoted to each responsibility (use increments of 5%, all time spent should total to 100% of time allocation). To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Please note the percentage of time spent on each job duty is an estimate for normal operating conditions.

1.

Actively participate as core team member in Shire´s cross-functional “QbD Center of Excellence”

Contribute to the vision, strategy and plan to guide all QbD involved departments & QbD related topics across Shire (covering Tech Ops, IT and R&D).

Contribute to establishment of QbD roadmap, timely coordinate implementation of assigned tasks and sub-projects.

10%

2.

Support the strategic development of the QbD/PV system with focus on Stage 1 related risk based methodologies

Including business aspects, compliance aspects, integration of all aspects of process development (among these: product & process risk assessments and development, integration of critical materials, equipment & utilities etc., into the methodology)

Own specific sub-process(es) of QbD including respective procedural and guidance documents with the focus on Stage 1 and risk based methodologies

Develop, maintain, and implement the respective QbD sub-process across all stages of the product lifecycle.

Define the needs from the QbD stakeholders & customers and drive request resolution through projects, training and coaching, and methodology development.

Support Stage 2.2 and Stage 3 related activities as applicable

30%

3.

Actively support systematic implementation, Deployment, and cultural integration for QbD with the focus on Stage 1 and risk based methodologies

Coach and train assigned sub-chapters cross-functionally to all executing functions

Closely collaborate with QbD-Program Management function for deployment of QbD within Shire

Drive standardization & harmonization of assigned QbD topics across all Shire sites and global PDTS & Other departments involved in QbD

Act as “best practice” facilitators for product- & process- specific risk assessments (including critical materials)

Support the teams on creation of process and analytical control strategies including execution of the associated risk management methods

Obtain feedback and best practices from sites and distribute information across the network

30%

4.

Represent QbD-Systems & Shire´s QbD methodology

in internal and external audits – present QbD related topics upon site-request

towards external stakeholders e.g. industry associations, regulatory authorities

at congresses

5%

5.

Support development, implementation and continuous improvement of IT solutions for QbD needs under consideration of customer feedback and QbD vision

Drive the creation of a harmonized IT infrastructure to support QbD requirements

Drive together with IT prioritization and roll-out of Stature / Discoverant and improvements

10%

6.

Serve as an expert in QbD related risk based methodologies

Ownership of Risk Management Methodology for Product and Process within Shire

Drive establishment of a flexible risk management methodology, which allows different developoment models (Fast to Clinic, Fast to Market).

Develop, maintain and continuously improve Shire´s risk management methodology – act as co-SME for risk management.

Own global procedural guidance documents for risk management.

Train, coach and assist risk management teams in implementing global requirements.

Give hands-on training and support for QbD-involved teams.

Provide adequate tools and templates for risk management related activities and deploy them.

Create and maintain training materials for risk management.

Contribute to implementation and continuous improvement of IT solutions for risk management.

Develop transfer “bridging” opportunities to align Shire internal risk management methodologies with external “CMO” tools.

15%

Education & Experience Requirements

Include educational requirements or equivalency, required years and type(s) of experience, and necessary licenses or certificates. Specify which are required and which are preferred. For UK, please do not use years of experience due to UK Legislation.

Essential: University degree (BS) in life sciences like biotechnology, biochemistry, pharmacy, process engineering or equivalent

Desired: Advanced degree (MS/PhD) in life sciences like biotechnology, biochemistry, pharmacy, process engineering or equivalent

Experience:

  • Minimum of 5 (BS/MS/PhD) years of professional experience in industry environment of an internationally operating company recommended – ideally at least half of them in pharma industry

  • Profound knowledge and expertise in the area of Process Validation / QbD /Statistical Process Control

  • Experience/Understanding of interactions with regulatory authorities and official bodies (FDA, EMA, etc.)

  • Experience in the management of small and medium global projects

  • Good knowledge of and appropriate compliance with guidelines as well as Shire internal requirements

  • Good knowledge of risk assessment tools

  • Basic understanding of external environment (political, economic, ecological, social, technical and legal)

Key Skills and Competencies

Describe critical skills needed to successfully perform job, which should be representative of the knowledge, skills and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Jobs in PDTS/QbD within this career band require a specific personal skillset reflecting their interdisciplinary & strategic impact:

  • Business acumen, strong strategic and process thinking

  • High degree of internal/external customer sensitivity/acumen

  • Uncompromised dedication to quality

  • Excellent written and verbal communication skills

  • Quick perception, analytical and abstract reasoning, solution oriented thinking, organizational talent, grasping new focus areas quickly

  • Ability to cope with pressure (flexibility in regard to continuous changing demands)

  • Cultural awareness when dealing with customers/regulators with a different cultural background

Leadership Behaviors:

  • Be Positive

  • Be Accountable

  • Be Results Oriented

  • Be An Excellent Manager of Self and Others

Other Job Components

Complexity and Problem Solving

Describe the decisions made by the incumbents on a regular basis. Include decisions within the incumbent’s authority to make as well as those decisions that must be referred to a higher level.

Works on problems of moderate scope in which analysis of situation or data requires review of identifiable factors.

Exercises judgment within defined procedures and policies to determine appropriate action.

Acts as advisor to unit or sub-units, becomes actively involved as required to meet schedules or resolve problems

Internal and External Contacts

List contacts this job advises, consults and coordinates with on a regular basis. Describe to whom this job is accountable. Indicate each Contact Category (Internal, Vendor, Customer, or Other) and provide examples.

  • Internal: Close collaboration with in PDTS and Manufacturing and Engineering

  • Vendor: Close collaboration with IT solution providers

  • External: Interaction with regulatory agencies during inspections and file review

Other Requirements

List any other job requirements, including domestic travel, international travel, driver’s license, physical abilities required, etc.

  • Travel: 10 %

Employee Signature:

Date:

Manager Signature:

Date:

Equal Employment Opportunity

Shire is an Equal Opportunity Employer committed to a diverse workforce. Shire will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.

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Reasonable Accommodations

Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.

Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.

Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.