Associate Project Manager - GMP , Data Integrity

Submission for the position: Associate Project Manager - GMP , Data Integrity - (Job Number: 188944)

PPD is a leading global contract research organization. At PPD we are passionate, deliberate, and driven by our purpose - to improve health.

PPD Laboratories offers the most comprehensive set of laboratory services available in the industry and continues to deliver innovative solutions to our clients through our collaborative approach, including PPD® Laboratories FSP. PPD® Laboratories FSP is a unique partnership that allows our clients to leverage the experience of our PPD staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits/advantages of being a part of PPD.

Job Purpose

Interface with external partners to collect GMP manufacturing and analytical data. The individual will also support the external supply manager in managing the relationship with the external partners, specifically ensuring adherence to the contract terms while maintaining a positive relationship with the partner. The individual is also responsible for monitoring performance against the relationship-specific KPls.

Key Responsibilities

• Collection of GMP Manufacturing and Analytical data from external partner

• Collating data into reports

• Assist in the transfer of documentation and uploads to GSK systems

• Manage Daily GSK Huddle(s) which includes reviewing manufacturing schedule, shipping schedule, issues and escalations, team deliverables, and batch release timelines

• Managing activities and/or services provided by external suppliers/contractors, including deviations, change controls, audit CAPAs and batch release

• Maintains relationships with internal partners and external suppliers whilst maintaining the highest level of professional and ethical conduct

• Travel to plant periodically for data collection or tasks

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

#LI-LM2

PPD is a leading global contract research organization. At PPD we are passionate, deliberate, and driven by our purpose - to improve health.

PPD Laboratories offers the most comprehensive set of laboratory services available in the industry and continues to deliver innovative solutions to our clients through our collaborative approach, including PPD® Laboratories FSP. PPD® Laboratories FSP is a unique partnership that allows our clients to leverage the experience of our PPD staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits/advantages of being a part of PPD.

Job Purpose

Interface with external partners to collect GMP manufacturing and analytical data. The individual will also support the external supply manager in managing the relationship with the external partners, specifically ensuring adherence to the contract terms while maintaining a positive relationship with the partner. The individual is also responsible for monitoring performance against the relationship-specific KPls.

Key Responsibilities

• Collection of GMP Manufacturing and Analytical data from external partner

• Collating data into reports

• Assist in the transfer of documentation and uploads to GSK systems

• Manage Daily GSK Huddle(s) which includes reviewing manufacturing schedule, shipping schedule, issues and escalations, team deliverables, and batch release timelines

• Managing activities and/or services provided by external suppliers/contractors, including deviations, change controls, audit CAPAs and batch release

• Maintains relationships with internal partners and external suppliers whilst maintaining the highest level of professional and ethical conduct

• Travel to plant periodically for data collection or tasks

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

#LI-LM2

Education and Experience:

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 0 to 2 years’) or equivalent combination of education, training, & experience.

Knowledge, Skills and Abilities: Good organizational skills with the ability to adapt and adjust to changing priorities and to manage multiple assignments with challenging/conflicting deadlines At least 1 year of GMP experience is required Prior Data Integrity Training is preferred Project Management Experience is preferred Prior 3rd party oversight experience is preferred Effective project management and organizational skills Good computer skills General knowledge of clinical trial processes and programs Strong attention to detail and problem solving skills Good written and verbal communication skills Ability to effectively conduct oral presentations Demonstrated experience in identification and resolution of technical problems in a professional environment Ability to maintain a high degree of confidentiality with clinical teams Ability to attain, maintain and apply a working knowledge of applicable procedural documents Demonstrated positive attitude, enthusiasm toward work, and the ability to work well with others

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.)  

Education and Experience:

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 0 to 2 years’) or equivalent combination of education, training, & experience.

Knowledge, Skills and Abilities: Good organizational skills with the ability to adapt and adjust to changing priorities and to manage multiple assignments with challenging/conflicting deadlines At least 1 year of GMP experience is required Prior Data Integrity Training is preferred Project Management Experience is preferred Prior 3rd party oversight experience is preferred Effective project management and organizational skills Good computer skills General knowledge of clinical trial processes and programs Strong attention to detail and problem solving skills Good written and verbal communication skills Ability to effectively conduct oral presentations Demonstrated experience in identification and resolution of technical problems in a professional environment Ability to maintain a high degree of confidentiality with clinical teams Ability to attain, maintain and apply a working knowledge of applicable procedural documents Demonstrated positive attitude, enthusiasm toward work, and the ability to work well with others

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.)  

Submission for the position: Associate Project Manager - GMP , Data Integrity - (Job Number: 188944)