Executive Director, Head of Healthcare Products Quality Assurance
Apply NowCompany: Organon
Location: Jersey City, NJ 07305
Description:
Job Description
The Position
The Executive Director, Head of Healthcare Products Quality Assurance (HPQA), reports to the Associate Vice President, Quality Systems and Compliance, Global Quality and supports all Quality and Good Practices Compliance activities related to medical device and combination product device component lifecycle management; owning and maintaining the complaint management systems, and acting as the Management Representative and Person Responsible for Regulatory Compliance for Organon's MedTech Portfolio.
Responsibilities
Required Education, Experience and Skills
Secondary Language(s) Job Description
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
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.
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 (US)
$204,100.00 - $347,300.00
Annualized Salary Range (Global)
Annualized Salary Range (Canada)
Please Note: Pay ranges are specific to local market and therefore vary from country to country.
Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites.
Flexible Work Arrangements:
Remote Work
Shift:
Valid Driving License:
Hazardous Material(s):
Number of Openings:
1
The Position
The Executive Director, Head of Healthcare Products Quality Assurance (HPQA), reports to the Associate Vice President, Quality Systems and Compliance, Global Quality and supports all Quality and Good Practices Compliance activities related to medical device and combination product device component lifecycle management; owning and maintaining the complaint management systems, and acting as the Management Representative and Person Responsible for Regulatory Compliance for Organon's MedTech Portfolio.
Responsibilities
- Act as the Management Representative, per the requirements outlined in ISO 13485:2013, and Person Responsible for Regulatory Compliance, per the European Union Medical Device Regulation (EU MDR), for the Organon, LLC legal entity acting as the legal manufacturer for Organon's MedTech portfolio globally.
- Establish, maintain and chair Organon's MedTech Management Review process, reporting to senior management regarding the health of the enterprise MedTech quality management system (QMS) processes as well as key indicators and trends for medical devices & device components of combination products that necessitate action.
- Working with stakeholders throughout the enterprise, enable one, standardized and integrated quality management system to support Organon's medical device and combination product portfolio to demonstrate sustainable compliance to standards and global regulation (ISO 13485:2013, 21 CFR 820, EU MDR, etc.).
- Establish & maintain a quality engineering team working collaboratively with stakeholders within Organon to manage the lifecycle of our portfolio of medical devices and device components of combination products.
- Establish & maintain a centralized complaint investigation team responsible for evaluating incoming device complaints or pharmaceutical product quality complaints and engaging the correct stakeholders within Organon.
- Ensure inspection and audit readiness for the Organon, LLC legal entity in collaboration with enterprise stakeholder organizations to demonstrate compliance with applicable regulations and standards for Organon's device and combination product portfolio,
- Support inspection and audit readiness for Organon's sites and entities globally for compliance to applicable regulations & standards for Organon's device and combination product portfolio,
- Ensure the ability to maintain required level of compliance with applicable regulations and standards (e.g., 21 CFR pt820, ISO 13485, MDR etc.),
- Identifies areas of continuous improvement, ensures best practice sharing and drives improvements across sites.
- Support and contribute to internal and external compliance forums to identify and evaluate emerging trends for continuous improvement related to medical devices and combination products (MDCP). These activities include:
- Surveillance to assess regulations, guidance, and regulatory intelligence to update Quality Management System (QMS) and develop action plans, where required.
- Attendance and participation in internal quality forums.
- Participation in industry working groups.
- Support enhancement of MDCP compliance performance through coordination with compliance leaders and representatives throughout Organon.
- Support business development and due diligence evaluations as requested related to medical devices and combination products.
- Support sites and quality operations leaders on fact finding and any recall, market action or field corrective action activities associated with medical devices and combination products.
Required Education, Experience and Skills
- Bachelor's degree in an appropriate scientific or engineering fields of study is required. Preferred fields of study include: Biology, Biochemistry, Chemistry, Engineering and Microbiology. An MBA or other business degree, in addition to the required science or engineering education is a plus.
- At least 15 years of work experience in a medical device, pharmaceutical, biologics and/or vaccine manufacturing environment, or a strongly related similarly regulated field.
- At least five years' experience directly related to MDCP's is required.
- Strong understanding of cGMPs, FDA, EMA, and ISO standards related to MDCPs.
- Strong compliance mindset.
- Excellent communication skills.
- Ability to work collaboratively in team settings, across divisions, and within matrix organizations to achieve objectives.
- Expert knowledge of US, EU and global medical device regulations and compliance in specialized area with experience of application, including current GMPs for MDCPs.
- Collaborate and lead cross-divisionally to drive continuous improvements, promote knowledge sharing and endorsement of best practices across sites, functions and divisions.
- Ability to work in a matrix environment and build strong relationships by being transparent, reliable and delivering on commitments.
- Demonstrated ability to work effectively in teams and manage up, coach and develop staff.
- Demonstrated leadership capability with the ability to work collaboratively across diverse teams and networks; able to foster cooperation in others.
- Effective written and oral communicator Able to apply prior experiences and learnings in new settings, even if these are unfamiliar.
Secondary Language(s) Job Description
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
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.
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 (US)
$204,100.00 - $347,300.00
Annualized Salary Range (Global)
Annualized Salary Range (Canada)
Please Note: Pay ranges are specific to local market and therefore vary from country to country.
Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites.
Flexible Work Arrangements:
Remote Work
Shift:
Valid Driving License:
Hazardous Material(s):
Number of Openings:
1