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Site Quality Head 工厂质量负责人
Your main responsibility is leadership and efficient operation of the Quality function of pharma manufacturing site. You are accountable for the quality oversight of the manufacturing site operations in compliance with GMP requirements and regulations in force, for the operational planning and cost, the performance of site Quality organization, employee development and taking responsibility as Qualified Person according to the Chinese regulation.
You set and assure adequacy of all quality systems and process, assures that all materials and products meet the registration requirement and specification. You are responsible for decisions made within the intent of cGMP, company, customer, and regulatory requirements. You provide overall leadership responsibility for the Quality Organization (team of 50-100 people) and is a member of the Site Leadership Team assuming responsibility for the leadership and governance at the site. You set the vision and establishes priorities for the Quality function in alignment with the strategic direction and focus for global Quality and site and adjusting priorities as necessary/in accordance with shifting business needs. You are accountable for effectively leading, driving and managing change for the functional area. You maintain effective internal auditing program to provide assurance that the site maintains a compliant state for internal and Health Authority audit. You implements/supports business process for continuous improvements in all areas of site operations. You collaborate with other stakeholders from Site Leadership, other quality leaders, Regulatory Affairs and Corporate function to assists in the implementation, continuous improvement and lifecycle management of implemented GMP policies and quality management system, implementing, updating the system GMP documents and standards. As Qualified Person, you are responsible for disposition process, detect risks of non-compliance and triggers preventive actions.
Who you are:
- Minimum of a Bachelor's of Pharmaceutical or related.
- Minimum of 10 years experience as a Quality Manager Leadership of a pharmaceutical &/or closely related equivalent.
- Fluent in English.
- Several years of distinctive experience in a leadership position managing a team.
- Experience with managing regulatory agency inspections.
- Comprehensive knowledge of global GMP regulatory requirements and hands-on experience with overseeing GMP operations in a commercial manufacturing facility.
- Demonstrated superior communication skills (verbal, written and presentation), influencing, interpersonal relation, collaboration, problem solving, effective facilitation and change management skills.
- Shows resilience and effective performance even in the face of significant obstacles and consistent resilience from stakeholders.
- Strong team building, interpersonal/negotiation skills including conflict resolution to complex problem with increasing legal and regulatory complexity.
- Highly ethical and transparent, with professional sensitivity and care for confidentiality.
- Work cross functionally to ensure the strategic and operational plans are delivered with excellent communication and strong presentation skills.
- Strong business intelligence, analytics, reporting and visualization, technical expertise.
- Demonstrated ability to successfully execute responsibilities in a fast-paced environment, collaborating across corporate functions and multiple internal and external stakeholders.
US Equal Employment Opportunities
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.
We are committed to an equitable hiring process for candidates from a diverse range of backgrounds. As part of this commitment, applicants with disabilities may be entitled to reasonable accommodations. Please contact USLeavesandAccommodations@milliporesigma.com, if a reasonable accommodation is needed or if you otherwise need assistance to participate in the hiring process.
North America Disclosure
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