Director, product safety job description
Updated March 14, 2024
10 min read
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Example director, product safety requirements on a job description
Director, product safety requirements can be divided into technical requirements and required soft skills. The lists below show the most common requirements included in director, product safety job postings.
Sample director, product safety requirements
- Bachelor's degree in safety engineering or related field.
- 5+ years of experience in product safety and risk management.
- Demonstrated experience with product safety regulations.
- Strong understanding of product development processes.
- Knowledge of quality management systems.
Sample required director, product safety soft skills
- Outstanding communication and interpersonal skills.
- Excellent organizational and problem-solving abilities.
- Strong leadership and mentoring capabilities.
- Ability to take initiative and work independently.
- High level of attention to detail.
Director, product safety job description example 1
RH director, product safety job description
RH at its core is about taste, and we believe the idea of scaling taste is large and far reaching.
The RH brand attracts the best designers, artisans, manufacturers and talent in our industry, scaling and rendering their work more valuable across our integrated platform, enabling us to curate the most compelling collection of luxury home furnishings in the world. We are moving the brand beyond curating and selling products to conceptualizing and selling spaces by building an ecosystem of products, places, services and spaces that elevates and establishes the RH brand as a global thought leader, taste and place maker.
At RH we believe deeply that the \"right\" people are our greatest asset. We value people with high energy, who possess the ability to energize others. People who are smart, creative and have a point of view. People who see the answer in every problem, versus those who see the problem in every answer. People who are driven, determined and won't take \"no\" for an answer. We value team players, people who are more concerned with what's right, rather than who's right.
The Product Compliance Director will lead all company activities designed to ensure that our products are safe and legal. The perfect candidate will have direct relevant experience in a similar setting and an immediate connection to our Core Values (People, Service, Quality and Innovation).
YOUR RESPONSIBILITIES
OUR REQUIREMENTS
RH is an equal opportunity employer and does not discriminate against any applicant on the basis of race, color, religion, national origin, gender, marital status, age, disability, sexual orientation, military/veteran status, or any other status protected by federal or state law or local ordinance.
The RH brand attracts the best designers, artisans, manufacturers and talent in our industry, scaling and rendering their work more valuable across our integrated platform, enabling us to curate the most compelling collection of luxury home furnishings in the world. We are moving the brand beyond curating and selling products to conceptualizing and selling spaces by building an ecosystem of products, places, services and spaces that elevates and establishes the RH brand as a global thought leader, taste and place maker.
At RH we believe deeply that the \"right\" people are our greatest asset. We value people with high energy, who possess the ability to energize others. People who are smart, creative and have a point of view. People who see the answer in every problem, versus those who see the problem in every answer. People who are driven, determined and won't take \"no\" for an answer. We value team players, people who are more concerned with what's right, rather than who's right.
The Product Compliance Director will lead all company activities designed to ensure that our products are safe and legal. The perfect candidate will have direct relevant experience in a similar setting and an immediate connection to our Core Values (People, Service, Quality and Innovation).
YOUR RESPONSIBILITIES
- Live Our Vision, Values and Beliefs every day
- Interact with cross functional teams, vendors and labs regarding testing, labeling and regulatory requirements and safety issues
- Drive day to day team functions including tactical decisions on testing requirements and product issues
- Provide technical and regulatory guidance for compliance, product and quality teams
- Monitor global regulations and industry standards and ensure RH's testing matrix is up to date
- Lead team efforts around product issue research and resolution and work closely with government agencies
- Develop and implement new product guidelines around safety and regulatory requirements
- Address vendor questions on regulatory and safety testing requirements
- Analyze testing data for trends and insights, present findings to cross-functional partners and implement changes based on analysis
- Run Data Analytics out of the merchandising database (QS- Mircostrategy)
- Maintain an up to the minute grasp of regulatory developments affecting the products RH offers
- Lead all efforts to prepare the business to comply with new product regulations
OUR REQUIREMENTS
- 7-10 years' experience in retail Product Compliance, ideally in home furnishings with international exposure
- Excellent data & analytical skills and a strong detail focus
- Advanced knowledge of Microsoft Excel, PowerPoint and Word are critical
- Ability to work in web-based, data-management, workflow and communication platforms like Salesforce is necessary
- Familiarity with product compliance and safety verification processes are necessary
RH is an equal opportunity employer and does not discriminate against any applicant on the basis of race, color, religion, national origin, gender, marital status, age, disability, sexual orientation, military/veteran status, or any other status protected by federal or state law or local ordinance.
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Director, product safety job description example 2
Amgen director, product safety job description
HOW MIGHT YOU DEFY IMAGINATION?
At Amgen, every challenge is an opportunity. And every opportunity brings the potential to change lives. Our shared mission-to serve patients-has driven our status as one of the world's preeminent biotechnology companies, reaching over 10 million patients worldwide. Leverage your high-level expertise to lead and forge partnerships that advance the biotechnical and biopharmaceutical science that can turn the tide of serious, life-interrupting illnesses.
Live
What you will do
Let's do this. Let's change the world. In this vital role the Executive Director, Combination Product Safety will provide science-based evaluation of product quality and device, companion diagnostic and digital health safety issues for Amgen products.
Responsibilities
Assess the potential impact of quality findings on patient/user safety for all clinical and commercial products Review adverse event data to detect potential product quality issues for commercial products Have expertise in combination product safety data collection, analysis and reporting in clinical trials. As well as post market surveillance and reporting, risk assessments, Human Factors study protocols and reports, and benefit/risk analyses Engage as a Safety expert in the therapeutic area and be accountable for the safety strategy, and major safety deliverables of the combination product therapeutic area Manage therapeutic area safety teams and be accountable for the staff management and resource planning/allocation Participate as a core member of Global Patient Safety (GPS) and Leadership Team to support the GPS, Vice President in the establishment of a highly effective global safety organization that will be in full compliance to worldwide regulations for combination products Lead all CPS (Combination Product Safety) staff in the assessment and management of combination product safety issues Lead CPS staff input to combination product risk management documents (hazard analysis, user risk assessments, etc.) for clinical and commercial products Ensure that CPS staff report assessment activities that take place for device complaints and malfunction Lead and provide medical oversight to CPS staff in the authoring of combination product risk/benefit analyses Provide clinical input in the development and maintenance of digital heath technology assets Undertake activities delegated by the Qualified Person for Pharmacovigilance (QPPV) as detailed in the Pharmacovigilance (PV) System Master File and maintain a state of inspection readiness Act as the representative and point of contact for Health Authority Inspections and Internal Process AuditsPerform management activities for direct reports, including mentoring, career development, and training, etc.
Win
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a leader with these qualifications.
Basic Qualifications
Doctorate degree & 6 years of product safety experience ORMaster's degree & 10 years of product safety experience ORBachelor's degree & 12 years of product safety experience AND6 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
Preferred Qualifications
MD or DO from an accredited medical school Five or more years of in industry and/or academic clinical research At least 5 years of experience with pharmaceutical/biotechnology/device pharmacovigilance/risk management Knowledge of global regulatory requirements, standards, and guidance's for pharmacovigilance/ risk management in relation to combination products and standalone devices An understanding of device risk management methodology, tools, and terminology; including human factors engineering methodology Familiarity with cGMP requirements and processes for drugs/biologics and devices/combination products An understanding of clinical and commercial drug/biologic pharmacovigilance/risk management processes
Thrive
What you can expect of us
As we work to develop treatments that take care of others, so we work to care for our teammates' professional and personal growth and well-being.
Clear and disciplined strategic vision for the future that leverages superior-quality products, operational excellence, and top-shelf-talent Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
Amgen's Commitment to Our Staff
At Amgen, our mission is serving patients. Our staff are dedicated to pushing the boundaries of science to transform medicine and turn the tide on serious illnesses. Central to achieving this mission is our “people-first” philosophy. We recruit the best talent, build an environment that facilitates career growth, and provide staff with the opportunity to make significant contributions for patients and our business.
Consistent with our core leadership value of “Develops the Best Team,” we are seeking leaders that prioritize the development of talent. As a manager, your priority and primary role is to accelerate the performance and development of your team. We expect managers to exemplify strong leadership and champion self-awareness and career development Ways that you will display your leadership acumen in this role include:
Mentoring, coaching, and developing staff to build highly skilled, diverse, and inclusive teams Fostering a positive and respectful work environment that encourages staff retention and motivates individuals to work toward common goals and priorities Ensuring that staff understand how their efforts and contributions make a meaningful impact to the business Growing core skills and capabilities among staff, particularly in learning agility, problem solving, strategic and creative thinking, flexibility, resilience, effective communication, prioritization, delivery of results, and continuous improvement Making accurate evaluations of your team's skills and competencies and providing timely and respectful feedback, including direct delivery of difficult messages Developing an understanding of your team's career objectives and serve as a thought-partner in their career development plans Assisting staff with preparing for roles of growing responsibility and identifying new opportunities that expand their skills and align with their overall career objectives Resolving critical gaps in the organization's internal capabilities and skillsets, including strategic external recruiting Identifying diverse, qualified successors for key positions Ensuring that direct reports who also lead people consistently demonstrate these same behaviors with their staff
We understand that to successfully sustain and grow as a global enterprise and deliver for patients - we must ensure a diverse and inclusive work environment.
Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment, and inclusion in all that we do.
MEANINGFUL IMPACT. To serve patients. We are all deeply committed to our mission: to serve patients. And we all have opportunities to contribute to that mission in meaningful ways. This creates a powerful sense of shared purpose.
INNOVATIVE: Stretch yourself at the cutting edge. You're poised to have a high impact in the new Bio century, Amgen offers our people interesting and challenging work.
REPUTATION. Be behind world-renowned products and services. With our industry reputation and strong product pipeline, you can take pride in working at Amgen.
COLLABORATIVE. Work alongside the best. Be part of our highly talented, hard-working teams. Their spirit is what fuels our success.
REWARDING. Get a fair share in success. Everyone's contribution is recognized - and strong performance is rewarded.
We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions.
Amgen focuses on areas of high unmet medical need and uses its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Amgen requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify based on a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.
This role is located in Thousand Oaks, CA or could be remote.
.
At Amgen, every challenge is an opportunity. And every opportunity brings the potential to change lives. Our shared mission-to serve patients-has driven our status as one of the world's preeminent biotechnology companies, reaching over 10 million patients worldwide. Leverage your high-level expertise to lead and forge partnerships that advance the biotechnical and biopharmaceutical science that can turn the tide of serious, life-interrupting illnesses.
Live
What you will do
Let's do this. Let's change the world. In this vital role the Executive Director, Combination Product Safety will provide science-based evaluation of product quality and device, companion diagnostic and digital health safety issues for Amgen products.
Responsibilities
Assess the potential impact of quality findings on patient/user safety for all clinical and commercial products Review adverse event data to detect potential product quality issues for commercial products Have expertise in combination product safety data collection, analysis and reporting in clinical trials. As well as post market surveillance and reporting, risk assessments, Human Factors study protocols and reports, and benefit/risk analyses Engage as a Safety expert in the therapeutic area and be accountable for the safety strategy, and major safety deliverables of the combination product therapeutic area Manage therapeutic area safety teams and be accountable for the staff management and resource planning/allocation Participate as a core member of Global Patient Safety (GPS) and Leadership Team to support the GPS, Vice President in the establishment of a highly effective global safety organization that will be in full compliance to worldwide regulations for combination products Lead all CPS (Combination Product Safety) staff in the assessment and management of combination product safety issues Lead CPS staff input to combination product risk management documents (hazard analysis, user risk assessments, etc.) for clinical and commercial products Ensure that CPS staff report assessment activities that take place for device complaints and malfunction Lead and provide medical oversight to CPS staff in the authoring of combination product risk/benefit analyses Provide clinical input in the development and maintenance of digital heath technology assets Undertake activities delegated by the Qualified Person for Pharmacovigilance (QPPV) as detailed in the Pharmacovigilance (PV) System Master File and maintain a state of inspection readiness Act as the representative and point of contact for Health Authority Inspections and Internal Process AuditsPerform management activities for direct reports, including mentoring, career development, and training, etc.
Win
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a leader with these qualifications.
Basic Qualifications
Doctorate degree & 6 years of product safety experience ORMaster's degree & 10 years of product safety experience ORBachelor's degree & 12 years of product safety experience AND6 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
Preferred Qualifications
MD or DO from an accredited medical school Five or more years of in industry and/or academic clinical research At least 5 years of experience with pharmaceutical/biotechnology/device pharmacovigilance/risk management Knowledge of global regulatory requirements, standards, and guidance's for pharmacovigilance/ risk management in relation to combination products and standalone devices An understanding of device risk management methodology, tools, and terminology; including human factors engineering methodology Familiarity with cGMP requirements and processes for drugs/biologics and devices/combination products An understanding of clinical and commercial drug/biologic pharmacovigilance/risk management processes
Thrive
What you can expect of us
As we work to develop treatments that take care of others, so we work to care for our teammates' professional and personal growth and well-being.
Clear and disciplined strategic vision for the future that leverages superior-quality products, operational excellence, and top-shelf-talent Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
Amgen's Commitment to Our Staff
At Amgen, our mission is serving patients. Our staff are dedicated to pushing the boundaries of science to transform medicine and turn the tide on serious illnesses. Central to achieving this mission is our “people-first” philosophy. We recruit the best talent, build an environment that facilitates career growth, and provide staff with the opportunity to make significant contributions for patients and our business.
Consistent with our core leadership value of “Develops the Best Team,” we are seeking leaders that prioritize the development of talent. As a manager, your priority and primary role is to accelerate the performance and development of your team. We expect managers to exemplify strong leadership and champion self-awareness and career development Ways that you will display your leadership acumen in this role include:
Mentoring, coaching, and developing staff to build highly skilled, diverse, and inclusive teams Fostering a positive and respectful work environment that encourages staff retention and motivates individuals to work toward common goals and priorities Ensuring that staff understand how their efforts and contributions make a meaningful impact to the business Growing core skills and capabilities among staff, particularly in learning agility, problem solving, strategic and creative thinking, flexibility, resilience, effective communication, prioritization, delivery of results, and continuous improvement Making accurate evaluations of your team's skills and competencies and providing timely and respectful feedback, including direct delivery of difficult messages Developing an understanding of your team's career objectives and serve as a thought-partner in their career development plans Assisting staff with preparing for roles of growing responsibility and identifying new opportunities that expand their skills and align with their overall career objectives Resolving critical gaps in the organization's internal capabilities and skillsets, including strategic external recruiting Identifying diverse, qualified successors for key positions Ensuring that direct reports who also lead people consistently demonstrate these same behaviors with their staff
We understand that to successfully sustain and grow as a global enterprise and deliver for patients - we must ensure a diverse and inclusive work environment.
Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment, and inclusion in all that we do.
MEANINGFUL IMPACT. To serve patients. We are all deeply committed to our mission: to serve patients. And we all have opportunities to contribute to that mission in meaningful ways. This creates a powerful sense of shared purpose.
INNOVATIVE: Stretch yourself at the cutting edge. You're poised to have a high impact in the new Bio century, Amgen offers our people interesting and challenging work.
REPUTATION. Be behind world-renowned products and services. With our industry reputation and strong product pipeline, you can take pride in working at Amgen.
COLLABORATIVE. Work alongside the best. Be part of our highly talented, hard-working teams. Their spirit is what fuels our success.
REWARDING. Get a fair share in success. Everyone's contribution is recognized - and strong performance is rewarded.
We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions.
Amgen focuses on areas of high unmet medical need and uses its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Amgen requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify based on a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.
This role is located in Thousand Oaks, CA or could be remote.
.
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Updated March 14, 2024
Updated March 14, 2024