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Compliance Manager/Assoc Compliance Director

Pharmaceutical Product Development (PPD)

United States

We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients.  

Our colleagues in quality strive for excellence in every task, at every moment. We are game changers seeking improvements to processes and more efficient ways of working or adapting to changing financial and industry environments.

As a Compliance Manager/Associate Director you will work from home in a group that does document control,overseeing the assessment and revision of controlled documents withinthisFDA regulated environment.

Summarized Purpose:

Identifies, develops and executes quality and compliance strategies and initiatives across the organization. Leads quality initiatives throughout operational departments. Identifies and mitigates risk and provides input to senior management. Maintains tools and materials that are essential to the execution of quality management systems. Provides leadership and expertise necessary to advance the vision of the department

Essential Functions: Manage the assessment of controlled documents against current standards Consult with Business Units regarding revision to SOPS, work instructions, and other controlled documents Provide Ad Hoc training or mentorship to document authors as needed Defines and leads quality and compliance responsibilities for quality system processes and engages with a variety of cross-departmental staff to ensure appropriate execution and completion (e.g. quality events, planned deviations, inspections and audits, vendor oversight). Identifies and mitigates risk through participation in risk management activities and/or the compilation and analysis of metrics and trends, and provides input to senior management Creates formal networks internally and externally involving coordination among groups.

At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees.

We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients.  

Our colleagues in quality strive for excellence in every task, at every moment. We are game changers seeking improvements to processes and more efficient ways of working or adapting to changing financial and industry environments.

As a Compliance Manager/Associate Director you will work from home in a group that does document control,overseeing the assessment and revision of controlled documents withinthisFDA regulated environment.

Summarized Purpose:

Identifies, develops and executes quality and compliance strategies and initiatives across the organization. Leads quality initiatives throughout operational departments. Identifies and mitigates risk and provides input to senior management. Maintains tools and materials that are essential to the execution of quality management systems. Provides leadership and expertise necessary to advance the vision of the department

Essential Functions: Manage the assessment of controlled documents against current standards Consult with Business Units regarding revision to SOPS, work instructions, and other controlled documents Provide Ad Hoc training or mentorship to document authors as needed Defines and leads quality and compliance responsibilities for quality system processes and engages with a variety of cross-departmental staff to ensure appropriate execution and completion (e.g. quality events, planned deviations, inspections and audits, vendor oversight). Identifies and mitigates risk through participation in risk management activities and/or the compilation and analysis of metrics and trends, and provides input to senior management Creates formal networks internally and externally involving coordination among groups.

At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees.

Education and Experience:

For Compliance Manager Bachelor's degree or equivalent and relevant formal academic / vocational qualification Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8 years).

For Associate ComplianceDirector Bachelor's degree or equivalent and relevant formal academic / vocational qualification Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 10 years)

Knowledge, Skills and Abilities: Effective oral and written communication skills Strong analytical thinking skills Effective understanding of strategic priorities and business needs Demonstrated leadership skills with ability to mentor and coach staff Ability to develop and execute sound strategies Excellent judgment and decision making skills Strong influencing and motivation skills Demonstrated organizational, time-management skills and attention to detail Ability to multitask and prioritize competing demands/work load Proven flexibility and adaptability Expert negotiation and problem solving skills Comprehensive knowledge and understanding of ICH GCP and other relevant regulations and guidelines Ability to work effectively in a team as well as independently Excellent writing and computer skills; ability to learn and become proficient with appropriate software

Working Environment:

PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.

Able to work upright and stationary for typical working hours.

Ability to use and learn standard office equipment and technology with proficiency.

Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

May require travel. (Recruiter will provide more details.)

PPD Defining Principles:

- We have a strong will to win - We earn our customer’s trust - We are gamechangers - We do the right thing -We are one PPD -

If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we’d love to hear from you.

PPD is an equal opportunity employer.

#LI-ER2

#LI-REMOTE

Education and Experience:

For Compliance Manager Bachelor's degree or equivalent and relevant formal academic / vocational qualification Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8 years).

For Associate ComplianceDirector Bachelor's degree or equivalent and relevant formal academic / vocational qualification Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 10 years)

Knowledge, Skills and Abilities: Effective oral and written communication skills Strong analytical thinking skills Effective understanding of strategic priorities and business needs Demonstrated leadership skills with ability to mentor and coach staff Ability to develop and execute sound strategies Excellent judgment and decision making skills Strong influencing and motivation skills Demonstrated organizational, time-management skills and attention to detail Ability to multitask and prioritize competing demands/work load Proven flexibility and adaptability Expert negotiation and problem solving skills Comprehensive knowledge and understanding of ICH GCP and other relevant regulations and guidelines Ability to work effectively in a team as well as independently Excellent writing and computer skills; ability to learn and become proficient with appropriate software

Working Environment:

PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.

Able to work upright and stationary for typical working hours.

Ability to use and learn standard office equipment and technology with proficiency.

Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

May require travel. (Recruiter will provide more details.)

PPD Defining Principles:

- We have a strong will to win - We earn our customer’s trust - We are gamechangers - We do the right thing -We are one PPD -

If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we’d love to hear from you.

PPD is an equal opportunity employer.

#LI-ER2

#LI-REMOTE

Job posted: 2021-04-21

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