Senior Specialist, Quality Management System
1 week ago
Support the management of Quality Management System (QMS), specifically:
- Overseeing and coordinating the development, revision, review, approval, and posting of QMS documents to improve, enhance or deployment of new Topic material.
- Own and manage an existing Topic that has been deployed
- The QMS Sr. Specialist is also responsible for ensuring the end-to-end life cycle process, under the guidance of the Chapter owner, for the QMS is well defined per the attributes of a quality system, there is a robust management system in place to monitor the process and that any gaps are identified and managed to completion. Processes are defined with adequate Procedures, Governance, and clear Roles, Responsibilities, and Accountabilities
Primary activities include, but are not limited to:
**Primary Responsibilities**:
- Co-Lead or lead a team of quality professionals, under the guidance of the Chapter owner, for the design, development, and implementation of the OMS QMS deployment strategy related to applicable QMS chapters.
- Lead cross-functional global teams developing content for the chapter, and interface with other chapters/topics, and stakeholders across the network as required.
- Supports the preparation, review, approval, and posting of all Quality Manual documentation including Core Requirements, Policies, Guidelines, SOPs, Quality Alerts, Quality Bulletins, White Papers, Best Practices, Flow Charts and Templates, and Training modules. Manage the QSC Workplan to prioritize document scheduling to optimize QSC workload and ensure triennial reviews are completed according to schedule.
- Monitor global regulations with impact on assigned topics to develop and sustain accurate interpretation of regulatory requirements per market, in alignment with QMS policies and procedures.
- Help identify, resolve/mitigate, or appropriately escalate any issues or delays in content development project execution, and ensure all targets are met on time, in full, and to quality.
- Administrative management of Chapter Continuity of Practices (COPs) and Sharepoints.
**Education Minimum Requirements**:
- B.S. or B.A. in Science, Pharmacy, Computer Science, or Business Administration
**Required Experience and Skills**:
- Thorough understanding of regulatory requirements for drugs, devices, and biologics, including risk management
- Minimum five years prior site and/or Global Quality experience in FDA and or EU-regulated pharmaceutical, vaccine, biologics, API manufacturing preferred.
- Minimum of five years of manufacturing and/or quality operation management experience (or equivalent) within an FDA and/or EU pharmaceutical, devices, and biologics environment.
- Must have strong analytical skills to develop and recognize appropriate action plans and how they will impact operations and compliance.
- Must have strong project management skills.
- Model behaviors consistent with Organon’s Leadership behaviors, values, and culture.
**Who We Are**:
Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman.
**US and PR Residents Only**
For more information about personal rights under Equal Employment Opportunity, visit:
EEOC Poster
EEOC GINA Supplement
OFCCP EEO Supplement
OFCCP Pay Transparency Rule
Organon proudly embraces diversity in all of its manifestations and is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity, or gender expression, national origin, disability, veteran status or any other characteristic protected by state or federal law.
**Search Firm Representatives Please Read Carefully**
**Applicable to United States Positions Only**:Under various U.S. state laws, Organon is required to provide a reasonable estimate of the salary range for this job. Final salary determinations take a number of factors into account including, but not limited to, primary work location, relevant skills, education level, and/or prior work experience. The applicable salary range for this position in the U.S. is stated below. Benefits offered in the U.S. include a retirement savings plan, paid vacation and holiday time, paid caregiver/parental and medical leave, and health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans.
**Annualized Salary Range**
91 300,00 $ - 155 200,00 $
**Employee Status**:
Regular
**Relocation**:
No relocatio
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