Project Manager - Home Based
FDA Quality and Regulatory Consultants (FDAQRC) provides trusted compliance solutions to pharmaceutical, biotech, and medical device companies.
From routine audits to inspection readiness to Quality Management System development, our Quality Assurance expertise spans all GxPs.
We are seeking candidates for the position of GCP Quality Project Manager.
Job PurposeThe Project Manager oversees the conduct of services provided by FDAQRC Consultants to Clients.
The GCP Quality Project Manager serves as a subject matter expert on GCP quality topics for our clients.
Primary Duties and ResponsibilitiesThe position is home-based.
The employee must provide a dedicated workspace.
Travel for internal business and to visit customers may occur but is not expected often.
Employees shall have a flexible working schedule and may be required to work outside of traditional hours to meet deliverable timelines.
Candidates should be well-versed in Good Clinical Practice as it applies to Quality.
FDAQRC has two (2) customers, Clients, and Consultants.
Customer service is what makes us successful and therefore each employee is expected to understand and demonstrate above-average customer service skills.
This results in high retention of our customers.
Clients:
Ensure client needs are identified and exceeded through effective project oversight.
Respond to queries and follow up on pending items through proactive communication.
Participate in the customer service program (sending and completing surveys).
Review feedback and action any quality issues Consultants:
Proactively engage consultants.
Manage consultant relationships.
Facilitate communication through various methods (email, phone, etc.
).
Ensure information is rapidly disseminated.
Provide materials so the project is set up for success.
Provide support through the time and expense review processes.
Review feedback and action any quality issues.
The Project Manager performs a wide range of duties, including some or all of the following:
Identifying and interviewing new consultants.
Conducting project management duties such as:
Conducting kick-off meetings and project status calls Completing meeting minutes and maintaining the Collaboration Plan Fulfilling both Client and Consultant needs Tracking deliverables/reports and updating project Stakeholders in the company Customer Relationship Management tool (HubSpot).
Evaluating the project against company-based success criteria Conducting peer reviews of deliverables/reports Supporting the needs of the FDAQRC Quality Management System (QMS) Conducting services in technical areas of expertise QualificationsExperienceAt a minimum, five (5) years of technical Quality Assurance (QA) experience.
Experience with internal and external audits is required.
Proven employee/resource management skills are required.
Additional experience in project management is desirable.
Quality or project management certifications and multi-language skills are desirable.
EducationUniversity Degree in a related subject.
Related certifications (Society of Quality Assurance, Regulatory Affairs Professional, Drug Information Association, etc.
) are highly desirable.
SkillsProficiency in the use of computers for the professional working environment such as Microsoft Office (e-mail, word processing (including track changes), spreadsheets, and graphs).
Requires the ability to work well with all levels of internal management and staff, as well as outside clients and vendors.
Sensitivity to confidential matters is required.
Knowledge, skills, and abilities in line with the duties and responsibilities described above.
CharacteristicsThe Project Manager should demonstrate competence in all the following:
Behave Ethically:
Understand ethical behavior and business practices and ensure that own behavior and the behavior of others is consistent with these standards and aligns with the values of the organization.
Communicate Effectively:
Speak, listen, and write in a clear, thorough, and timely manner using appropriate and effective communication tools and techniques.
Creativity/Innovation:
Develop new and unique ways to improve operations of the organization and to create new opportunities.
Foster Teamwork:
Work cooperatively and effectively with others to set goals, resolve problems, and make decisions that enhance organizational effectiveness.
Lead:
Positively influence others to achieve results that are in the best interest of the organization.
Make Decisions:
Assess situations to determine the importance, urgency, and risks, and make clear decisions that are timely and in the best interests of the organization.
Organize:
Set priorities, develop a work schedule, monitor progress towards goals, and track details/data/information/activities.
Plan:
Determine strategies to move the organization forward, set goals, create and implement action plans, and evaluate the process and results.
Solve Problems:
Assess problem situations to identify causes, gather and process relevant information, generate workable solutions, and make recommendations and/or resolve the problem.
Recommended Skills Auditing Biotechnology Business Ethics Creativity Customer Relationship Management Ethics Estimated Salary: $20 to $28 per hour based on qualifications.
From routine audits to inspection readiness to Quality Management System development, our Quality Assurance expertise spans all GxPs.
We are seeking candidates for the position of GCP Quality Project Manager.
Job PurposeThe Project Manager oversees the conduct of services provided by FDAQRC Consultants to Clients.
The GCP Quality Project Manager serves as a subject matter expert on GCP quality topics for our clients.
Primary Duties and ResponsibilitiesThe position is home-based.
The employee must provide a dedicated workspace.
Travel for internal business and to visit customers may occur but is not expected often.
Employees shall have a flexible working schedule and may be required to work outside of traditional hours to meet deliverable timelines.
Candidates should be well-versed in Good Clinical Practice as it applies to Quality.
FDAQRC has two (2) customers, Clients, and Consultants.
Customer service is what makes us successful and therefore each employee is expected to understand and demonstrate above-average customer service skills.
This results in high retention of our customers.
Clients:
Ensure client needs are identified and exceeded through effective project oversight.
Respond to queries and follow up on pending items through proactive communication.
Participate in the customer service program (sending and completing surveys).
Review feedback and action any quality issues Consultants:
Proactively engage consultants.
Manage consultant relationships.
Facilitate communication through various methods (email, phone, etc.
).
Ensure information is rapidly disseminated.
Provide materials so the project is set up for success.
Provide support through the time and expense review processes.
Review feedback and action any quality issues.
The Project Manager performs a wide range of duties, including some or all of the following:
Identifying and interviewing new consultants.
Conducting project management duties such as:
Conducting kick-off meetings and project status calls Completing meeting minutes and maintaining the Collaboration Plan Fulfilling both Client and Consultant needs Tracking deliverables/reports and updating project Stakeholders in the company Customer Relationship Management tool (HubSpot).
Evaluating the project against company-based success criteria Conducting peer reviews of deliverables/reports Supporting the needs of the FDAQRC Quality Management System (QMS) Conducting services in technical areas of expertise QualificationsExperienceAt a minimum, five (5) years of technical Quality Assurance (QA) experience.
Experience with internal and external audits is required.
Proven employee/resource management skills are required.
Additional experience in project management is desirable.
Quality or project management certifications and multi-language skills are desirable.
EducationUniversity Degree in a related subject.
Related certifications (Society of Quality Assurance, Regulatory Affairs Professional, Drug Information Association, etc.
) are highly desirable.
SkillsProficiency in the use of computers for the professional working environment such as Microsoft Office (e-mail, word processing (including track changes), spreadsheets, and graphs).
Requires the ability to work well with all levels of internal management and staff, as well as outside clients and vendors.
Sensitivity to confidential matters is required.
Knowledge, skills, and abilities in line with the duties and responsibilities described above.
CharacteristicsThe Project Manager should demonstrate competence in all the following:
Behave Ethically:
Understand ethical behavior and business practices and ensure that own behavior and the behavior of others is consistent with these standards and aligns with the values of the organization.
Communicate Effectively:
Speak, listen, and write in a clear, thorough, and timely manner using appropriate and effective communication tools and techniques.
Creativity/Innovation:
Develop new and unique ways to improve operations of the organization and to create new opportunities.
Foster Teamwork:
Work cooperatively and effectively with others to set goals, resolve problems, and make decisions that enhance organizational effectiveness.
Lead:
Positively influence others to achieve results that are in the best interest of the organization.
Make Decisions:
Assess situations to determine the importance, urgency, and risks, and make clear decisions that are timely and in the best interests of the organization.
Organize:
Set priorities, develop a work schedule, monitor progress towards goals, and track details/data/information/activities.
Plan:
Determine strategies to move the organization forward, set goals, create and implement action plans, and evaluate the process and results.
Solve Problems:
Assess problem situations to identify causes, gather and process relevant information, generate workable solutions, and make recommendations and/or resolve the problem.
Recommended Skills Auditing Biotechnology Business Ethics Creativity Customer Relationship Management Ethics Estimated Salary: $20 to $28 per hour based on qualifications.
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