PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory, and lifecycle management services.  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. 

This position is accountable for execution of day-to-day onsite contractor activities specific to GMP controlled issuance, lifecycle information management and role-based training delivery in support of the manufacture and testing of BPDS internal and external assets. Following instruction and work priority guidance from the Client department director, the incumbent will provide oversight for all daily activities performed by the contract team (e.g. leading new user training and embedding broad utilization of Veeva Quality Docs (VQD), day-to-day assignment of training via role-based training).

Specific responsibilities include end-to-end oversight of critical GxP activities (generating, editing, issuing, reconciling, archiving of manufacturing batch proforma, logbooks, specifications, equipment methods, protocols, reports, analytical methods, media/buffer forms). The incumbent will drive compliance system enhancements that ensure core activities are fulfilled and align to in-use global quality policies. Deliverables in scope are time-sensitive and require the incumbent to be flexible in adapting to asset manufacturing schedules and timelines. 

Following priority and work direction, the selected candidate is also expected to work on projects and problems of diverse scope while self-identifying opportunities and fulfilling organizational expectations aligned to compliance systems analysis, delivery and solution architecting. Activities may also include assessing, modeling and implementing technology solutions to satisfy identified deliverables in collaboration with process owners, stakeholders, management and the global MST community. This role also has a targeted focus on enabling and operationalizing available tools and technology that simplify compliance systems adherence (e.g. Power BI).  

Key Responsibilities:

• Right first time (RFT) MyLearning oversight of lead training coordinator activities for all document/data management deliverables, including but not limited to effective item updates and content loading, issuance of Internal and external mini-manuals (as applicable), primary support for site questions on training curricula and Veeva Quality Docs (VQD), face-to-face training aligned to system access deliverables, authorized content loading, management of training periods including flexibility for early effective release and associated OJT training.

• Controlled issuance and reconciliation oversight accountabilities specific to applicable proforma (batch records, media forms, logbooks, protocols, etc.) required for execution within onsite manufacturing areas.

• Document attribute and content quality editing on Controlled Documents (SOPs, Instructions, Material Specifications, Analytical Methods, Validation Protocols, etc.) that align with regulatory expectation and Client SOPs.

• Author training and support in creating documents and workflows within Veeva Quality Docs (VQD) with front-facing direct support on the use of Microsoft Word advanced functionalities (styles, cross-references, tables, picture, embedded objects, etc.). Examples include assurance that documents render properly in Veeva Quality Docs and that the appropriate reviewers and approvers are assigned to workflows.

• Obtaining, tracking and organizing project-specific data from various data repositories/ SharePoint systems in support of external partnerships as required.

• Interfacing with various departments inside/outside of BPDS as required to obtain reports, protocols, methods, memos, notebooks, batch records and other forms of GMP documentation that will support BLA filings.

• Audit support specific to retrieval of key documents and requested training records for internal Client and external regulatory inspection.

• Onsite scanning activities of reconciled documentation in support of regulatory submissions and as a vital records backup measure.

• Coordinating the issuance and reconciliation of batch records and logbooks using both manual and electronic document management systems as assigned.

• Other related documentation tasks and training as assigned.

Additional Responsibilities

• Application of knowledge and leveraging of continuous improvement activities utilizing available tools where applicable that support continued adherence with industry regulations, Global Quality Policies (GQP 3201A and GQP 3201B) and supporting business procedures.  

• Leads the preparation and delivery of targeted training materials and user guides aligned to promote broader adoption and increased knowledge of BPDS compliance systems.  Designs and conducts user training sessions, with emphasis on increasing user awareness and engagement on tools and templates that simplify manufacturing and aligned compliance processes.    

• Proactively communicates the status of critical compliance systems support and problem resolution.  Ensures effective problem analysis and resolution of issues of diverse scope in a timely fashion and escalates issues when needed to appropriate levels of QRMC management.

• Applies metric generation and reporting for QRMC-led quality processes (periodic review, controlled issuance, reconciliation, etc.).  

• Ensures lifecycle management that includes archiving QRMC-DC controlled issued documentation to Records Management and Administration (RMA) via VQD and the PIER R&D archival system.  

• Works collaboratively via continually embracing Client Values and Expectations while effectively implementing solutions. Develops and maintains mutually productive relationships in the workplace. Builds and leverages their own networks of expertise formed with other senior internal and external personnel for the benefit of the team.

• Leads the identification and implementation of strategies to improve the qualities and efficiencies of QRMC processes, systems and results. Maintains strong compliance systems understanding of current technologies and professional concepts.    

• Responsible for scheduling and planning work to meet priorities set by supervision.  Sets specific daily and weekly priorities to meet timelines.  Recommends procedures and policies to supervision.

EDUCATION AND EXPERIENCE:

• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years) or equivalent and relevant combination of education, training, & experience.

• 1+ year of leadership responsibility

KNOWLEDGE, SKILLS AND ABILITIES:

• Administration of learning management systems within a GxP environment required 

• Management of lifecycle document management systems as an administrator required

• 3 years compliance systems experience preferred

• Experience with Core Quality Systems in a GMP environment (for example, Deviation Handling, CAPA Management, Change Management, Documentation authoring/approval, or Validation Lifecycle Documentation)

• Strong interpersonal skills required

• Strong verbal and written communication skills required

• Experience with controlled document computer systems required

• Keeps current on governmental regulatory requirements and Client standards related to biopharmaceutical clinical manufacture and control

• Experience with learning management systems preferred

• Experience with analysis and visualization tools (e.g. Power BI, Spotfire) preferred

• Biotechnology experienced preferred

• Knowledge of manufacture and/or testing of Biopharmaceutical Bulk Drug Substance (BDS)

• Ability to communicate, influence and negotiate at various levels

• Broad knowledge of the R&D Drug Development Process preferred

• Ability to effectively mentor and provide direction to staff

• Knowledge of FDA regulations and applicable global pharmaceutical industry guidelines

• Knowledge of analytical methodologies, instrumentation and method validation required for Lab QA Management

• Good verbal and written communication skills

• Demonstrated proficiency with regulations and guideline interpretation, audit procedures, proper documentation and QA departmental policies and procedures

• Detail oriented with ability to deal with multiple and changing priorities

MANAGEMENT ROLE:

Manages experienced professionals and / or subordinate management who exercise latitude and independence in their assignments. Often heads one or more sections or a small department.

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:

• Work is performed in an office and/or laboratory and/or clinic environment with exposure to electrical office equipment.

• 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.

• Able 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.

• This role requires independent travel up to XX%, inclusive of traveling in automobiles, airplanes, and trains. 

• As a condition of employment with PPD, in this role, you must have received your Covid-19 vaccine and you must disclose proof of your vaccination status upon employment.

As the world’s leader in serving science, Thermo Fisher Scientific's professionals develop critical solutions—and build rewarding careers. They help customers in finding cures for cancer, protecting the environment, making sure food is safe, and so much more. When you #StartYourStory with Thermo Fisher, you are guaranteed meaningful work - both personally and professionally.