- To provide leadership and oversight to the Quality Systems & Compliance function, and continuously develop people and teams.
- To drive compliance to regulations and Takeda global standards and processes.
- To ensure the quality, safety and compliance of plasma-derived products released to the market.
- Manage through subordinates the coordination of the activities of several functions within the Quality organization including the Deviation/CAPA and Change Control quality systems, Validation Quality, Compliance, and Product Complaint Management.
- Establishes goals for the Quality Systems & Compliance department in alignment with the global and site strategy, and takes action as needed to ensure timely delivery of goals.
- Responsible for ensuring compliance with all applicable provisions of the Takeda Quality Management System, and the regulations and standards applicable to Round Lake operations.
- Conducts gap analyses and implements Quality Management System procedures in several departments and manages compliance.
- Understands and assures conformance to applicable regulations. Interfaces with regulators during inspections in the roles of escort and SME concerning Deviation/CAPA, Change Control quality systems, and Product Complaint Management.
- Responsible for Quality Management Review meetings, including summaries of the data presented, conclusions, meeting minutes, and tracking action of items to closure.
- Responsible for the submission of annual Product Quality Reviews and quarterly reports.
- Reviews site-impacting regulatory submissions working with Subject Matter Experts to assure timeliness and accuracy. Manages the Product Complaint Management process and coordinates complaint escalations for review and product hold, BPDR, and Field Corrective Action decision.
- Responsible for Validation Quality and the oversight of the site Validation Master Plan and Engineering Validation activities.
- Seeks new ways to improve and streamline current business and system processes. Identifies, manages, and where appropriate, leads multiple process/product improvement projects with the objective of achieving quality, efficiency and cost improvements.
- Owns and approves Deviation/CAPA investigations related to FLEXBUMIN operations.
- Responsible for the coaching, training, and development of the Quality Systems & Compliance team.
- Develops budget for department and ensures adherence to the budget.
Technical/Functional (Line) Expertise:
- Knowledge of the local and international regulatory regulations for the manufacture of biological products.
- Strong analytical and problem solving skills.
- Excellent verbal and written communication skills in English.
- Adaptive communication and presentation skills to effectively reach different levels, including senior management.
- Experience/expertise with TrackWise Deviation/CAPA, Change Control Management (CCM), JDE/C3ME and Electronic Batch Management (EBM) systems preferred.
- Skilled in Microsoft Office applications (Excel, Powerpoint, Word)
- Strong leadership skills and demonstrated success in managing a team.
- Excellent interpersonal, communication, influencing, and negotiation skills.
- Must have the ability to act as a change agent as well as effectively lead and motivate team members to achieve team goals.
- Must be able to deal with ambiguity, and make decisions under stressful conditions.
- Strong knowledge of Quality Risk Management principles.
- Should be current in knowledge of state-of-the art processes and systems related to production as well as control of the products.
Education/ Additional Requirements:
- BS in Science or Engineering; advanced degree a plus.
- Minimum of 7 years of experience in Quality, Aseptic Manufacturing (preferably with strong focus on fill/finish operations) or related field in the pharmaceutical industry.
- 5 years of management experience.
- Demonstrate the Takeda Leadership Behaviors; be positive, accountable, and be an excellent manager of self and others.
- Cannot be allergic to Cephalosporin drugs to apply for this position.
- Must be able to work in controlled/classified environments requiring special gowning. Required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body when working in those areas.
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.
EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf
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.