This position supports site projects, technical transfers, and ongoing validation maintenance. Primarily responsible for QA oversite in the design, authorship, and execution of commissioning, qualification and/or validation studies for the any or more of the following major disciplines:
- Facilities, Utilities, and Equipment (FUE) qualification
- Unit operations automation qualification with Honeywell, Delta V, and PLC-based systems
- Computerized systems validation
- Cleaning validation
- Sterilization validation
- Materials qualification
- Process validation
Job Function and Description
- Implements the quality systems procedures and manages compliance in a section or department.
- Understands and assures conformance to regulations in a section or department. Interfaces with regulators during regulatory inspections.
- Identifies and manages continuous improvement projects with the objective of achieving quality, reliability and cost improvements.
- Develops budget for a section or department and ensures adherence to the budget.
- Manages the coaching, training and development of subordinates.
- Responsible for Quality oversite of validation standards.
- Oversees the Quality approval of commissioning, qualification and validation program, and drives innovation to remain current and compliant. Oversees the development and implementation of validation strategy for the portfolio of products and/or across validation functions.
- Attracts, develops, and retains a high performing team to meet the current and evolving needs of the business through effective selection, training and development, coaching and mentoring and performance management. Manages Quality Validation function, including organizing and prioritizing departmental goals and objectives.
- Collaborates cross-functionally with stakeholders to ensure that validation processes are aligned to the needs of the organization, ensuring best practice and compliance alignment with business needs.
- Interfaces with regulatory agencies as required representing the organization to authorities and regulatory inspectors in matters relating to GMP. Approves regulatory submissions.
- Establishes and publishes key performance indicators to track GMP compliance across operations.
- Provides leadership and guidance to direct reports and project team members.
- Acts as an escalation point for quality issues/decisions.
- Typically requires bachelor's degree, preferably in science, engineering or other related technical field. 6+ years of related experience with 1+ in a management role
- A minimum of 3 years of relevant experience in a GMP regulated environment required.
- At least 2 years of commissioning, qualification and validation (CQV) required.
- At least 2 years of personnel supervision experience highly desired.
- At least 2 years of project management experience highly desired.
- Direct experience with manufacturing operations, biotechnology processes, biopharmaceutical or pharmaceutical experience required.
- Validation and/or system experience in the following applicable areas:
- Sterilization and aseptic processing validation.
- Cleaning validation of manufacturing equipment.
- Process and utility systems validation, temperature mapping, manufacturing equipment commissioning and qualification.
- Protein purification from mammalian plasma and/or blood.
- Technical understanding and experience of automation platforms, such as DeltaV, Honeywell, Rockwell PLC, Siemens XFP.
- Thinks strategically. Quickly identifies and acts on opportunities. Considers the downstream impact. Seeks to understand the why.
- Acts decisively. Makes and acts on decisions quickly. Makes decisions with the customer and their patients in mind. Meets commitments with a sense of urgency. Seeks ways to be more efficient.
- Drives performance. Holds self and others accountable. Delivers results first time right. Never settles for status quo. Willing to have tough conversations. Asks for feedback and takes action to improve.
- Works collaboratively. Seeks out the experience of others with the aim for better results. Open minded regardless where ideas originate. Flexible and easy to work with.
- Excellent communication and attention to detail skills.
- Knowledge of Industry guidelines (ISPE, PDA), US and international regulations (FDA, ICH, ISO, EU) for GMP regulated environments.
- Strong organizational skills, excellent writing and communications skills.
- Must be well versed in validation disciplines. Must possess knowledge of related disciplines.
- Proven track record of management / leadership effectiveness.
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.
Equal Employment Opportunity
Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, 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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EEO is the Law Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf
Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf
Shire, a wholly-owned subsidiary of Takeda, 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.