Associate Vice President, Research & Development Quality Assurance

Job Description

Organon is a Womens Health Company that believes in a better and healthier every day for every woman! We are a passionate, global community of thousands dedicated to redefining the future of womens health. Our mission is to deliver impactful medicines and solutions for a healthier every day. But what really makes it work at Organon is our people.

Were looking for real, passionate team players, curious innovators, forward thinkers, empowered by the idea of shaping their career, and ready to bring their fire to embrace change and the opportunities it brings for progress.

At Organon, youll get to enjoy the best of both worlds: the open, agile, collaborative culture of a start-up, and operating at the scale of a Fortune 500 company with an international footprint that serves people in more than 140 markets.

Its going to be an exciting futurecome be a part of it!

Reporting to the Head of Research & Development (R&D) Quality, Systems and Sourcing, the Associate Vice President - Head of Quality Assurance (QA) leads the R&D QA organization to establish and oversee the end-to-end quality strategies for all activities within the R&D organization. This leader is the single QA point of contact across all QA activities for R&D and the R&D Quality System and supports the organization in the integrated capacity of Process, Standard Operating Procedures, Training, Audits, and Inspections.

The Head of Quality Assurance is responsible for overseeing a broad set of areas which includes a matrixed set of R&D functions and regions globally including Regulatory Affairs, Global Pharmacovigilance and Safety Science, Clinical Development, Preclinical Development, Labeling, Medical Affairs, Quality Management Systems, SOP/Process Management/Document Control, Compliance Training, Audit Support, Inspection Support, Issue Management, Internal Pharmacovigilance (PV) Audits and Process Audits. This leader is also responsible for conducting due diligence activities in quality for possible business development opportunities, vendor qualification audits, external business development partner & audits, commitment tracking, and oversight of outsourced study quality as well as data integrity.

The Head of Quality Assurance is responsible for evaluating the regulatory environment globally for key regulatory compliance changes driving assessment, modification and training across SOP/Process Management and Document Control.

The Head of Quality Assurance assesses business challenges and compliance risks and provides further definition, drive and oversight for the overall QA activities through the organization. Through Quality oversight, this leader ensures substantial Quality, upholding the rights and welfare of patients and assures adherence to relevant Good Practice guidelines (GxPs), covering end to end QA activities across all therapeutic areas globally. This leader collaborates across Commercial, Manufacturing and Corporate functions to ensure end-to-end regulatory compliance globally and will be responsible for various additional corporate activities as they related to R&D such as data privacy, enterprise risk management, business continuity planning, US transparency, environmental health & safety (EHS), incident & crisis management, and reporting to the ESG Committee of the Board of Directors.

The Head of Quality Assurance ensures Quality principles are proactive, considered and incorporated when designing new programs and ongoing initiatives, using Quality by Design (QbD) principles, and ensuring appropriate interfaces across Commercial, Manufacturing and Corporate functions. This leader builds Quality into collaborations with partners or vendors which provide clinical and non-clinical study execution and services and pharmacovigilance activities. S/he drives development, advancement and utilization of Quality metrics including audit and other Quality data to inform the business of the state of Quality of the programs. This leader maintains a current knowledge of relevant industry and health authority quality trends as well as building and maintaining an industry network.

Primary Responsibilities:

• Leads the QA organization and provides QA strategic guidance in key Quality matters for all R&D activities.

• Develops, drives and executes long term QA vision and strategy for all R&D activities.

• Provides industry expertise and practical knowledge of current and emerging global guidelines and regulations and implements required SOP/Process Management/Document control and training to comply with regulatory requirements.

• Acts as the Data Privacy Officer for R&D.

• Maintains knowledge of relevant regulatory approaches and actions, and status of competitor/similar products/projects, disease area and unique needs of the clinical areas to effectively develop and advance end to end QA strategies.

• Leads R&D QA in the assessment and development of risk mitigation strategies and partners with R&D leaders and cross-functional lines for continuous management of quality issues across therapeutic area projects and products.

• Provides QA support with regional consideration R&D projects, studies and accountabilities to ensure they are reflected in the relevant global QA strategy. This will be accomplished through close partnership with relevant functional support areas across R&D.

• Leads strategy and appropriate activities to ensure the company is in a constant state of inspection readiness across all functions through continuous education, training and internal audits.

• Oversight for all R&D Learning and Development activities.

• Inspires, develops and manages a high functioning team across a variety of cultures, languages and backgrounds.

• Ensure high ethical standards and a culture that values honesty, integrity, and transparency.

Education Minimum Requirements:

• Bachelors degree in a scientific or operational discipline relevant to the life sciences and/or operations areas is required.

Required Experi ence and Skills:

• 20+ years relevant Quality Assurance experience in global pharmaceutical R & D organization, including at least 5 years in senior leadership role (e.g., therapeutic area, region).

• Breadth of experience across a range of scientific fields including clinical quality management, biomedical science, clinical development, regulatory strategy, or equivalent experience.

• Demonstrated knowledge of ICH GCP, GLP, GRP and GPvP, clinical development and principles of quality assurance.

• Experience leading a global organization though successful quality inspections and audits; maintaining a quality and compliance ready mindset.

• Experience in oversight outsourced clinical (and non-clinical) development and pharmacovigilance activities.

• High level of credibility in the external environment including relevant authorities around the world.

• Proven track record of leading high functioning global and diverse teams.

• Demonstrated ability to attract, lead, and inspire key talent.

• Proven ability to set an ambitious vision and mobilize commitment and resources to achieve such.

• Proven track record of effectively working across organizational boundaries.

• Strong knowledge and understanding of general healthcare environment laws and regulations worldwide.

• Demonstrated ability to communicate and collaborate effectively with internal and external stakeholders and audience.

• Must have proven track record to be able to think critically, strategically, independently and problem solve.

• Must have high level of motivation, drive, and demonstration of our Company's leadership values.

• Excellent written and verbal communication skills including ability to write clearly and concisely.

• Top notch interpersonal skills in difficult situations.

• Driver of change and innovation.

• Ability to work seamlessly with all levels of personnel.

• Demonstrated sensitivity and knowledge of cultural differences with experience in multi-country, multi-cultural environments and demonstrated success with cross-geographically based cultural collaborations.

• Excellent word processing, PowerPoint, SharePoint, Excel, e-mail, and online meeting tool skills.

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 Womens 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.

Subject to applicable law, all prospective US Organon hires will be required to demonstrate that they have been fully vaccinated against COVID-19 with a vaccine authorized or approved by the Food and Drug Administration (FDA), or qualify for a medical or religious accommodation to this vaccination requirement, as a precondition of employment.

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US and PR Residents Only

If you require reasonable accommodation(s) in completing an application, interviewing, or otherwise participating in the employee selection process, please email us at {apply below} .

For more information about personal rights under Equal Employment Opportunity, visit:

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Organon is an equal opportunity employer, Minority/Female/Disability/Veteran - proudly embracing diversity in all of its manifestations.

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Organon LLC., does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

Domestic

VISA Sponsorship:

No

Travel Requirements:

25%

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1

Requisition ID: R509723