Project manager/quality control manager job description

Come Be Part of a Mission that Matters!
The Animal Safety Division is currently seeking a candidate for a Quality Control Unit (QCU) Project Manager. The ideal candidate will have 2-3 years of project management experience in pharmaceutical manufacturing; PMP or PRINCE II certification a plus. Additionally, the candidate will have demonstrated proficiency in technical writing.
The selected candidate will be responsible for facilitating projects that are delivered on-time, within scope and within budget; setting and meeting realistic deadlines; developing project scopes and objectives; determining resource availability and allocation; developing a detailed project plan to track progress; managing changes to project scope, schedule, and cost; performing risk management; measuring project performance; creating and maintain project documentation; creating and maintaining relationships with third parties; acquiring quotes and preparing CARFs; and assisting in the preparation of technical and regulatory documents.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Facilitate projects that are delivered on-time, within scope and within budget.Set and meet realistic deadlines. Communicate changes and projected issues.Develop project scopes and objectives, involving all relevant stakeholders to ensure technical feasibility.Determine resource availability and allocation.Develop a detailed project plan to track progress.Manage changes to project scope, schedule, and cost.Perform risk management to minimize project risks.Measure project performance.Create and maintain comprehensive project documentation.Establish and maintain relationships with third parties/vendors.Acquire quotes and prepare CARFs.Assist in the preparation of technical and regulatory documents.Ability to manage multiple projects.

EDUCATION and/or EXPERIENCE: BA/BS in business with focus on project or product management or 2-3 experience in project or product management in a related field.

JOB REQUIREMENTS/QUALIFICATIONS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The individual must possess a clear understanding of the performance of various products, how to trouble-shoot problems and must be able to work independently to complete projects and reports. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

LANGUAGE SKILLS: Ability to read, analyze and interpret common regulatory documents, technical procedures, and data. Ability to write reports business correspondence, and procedure manuals. Ability to effectively present information to and respond to questions from management and public groups.

MATHEMATICAL AND COMPUTER SKILLS: Ability to work with mathematical concepts such as probability and statistical inference. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations. Ability to work with computer programs such as Excel, Word, PowerPoint, Windows, and other software.

REASONING ABILITY: Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret a variety of instructions furnished in written, oral, diagram, mathematical, or schedule form and deal with several abstract and concrete variables.

CERTIFICATES, LICENSES, REGISTRATIONS: PMP or PRINCE II certification a plus.

TRAVEL EXPECTATIONS: Minimal. Expected to attend applicable training seminars related to position. These seminars may require overnight travel.

PHYSICAL DEMANDS: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this Job, the employee is regularly required to talk or hear. The employee is frequently required to stand, walk, sit and use hands to finger, handle, or feel. The employee is occasionally required to reach with hands and arms and climb or balance. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision and color vision.

WORK ENVIRONMENT: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate.

WHO IS NEOGEN:

From farm to fork, we offer solutions to enhance the quality, quantity and safety of the global food supply. Our animal safety solutions are used on farms, veterinary practices and manufacturers around the world to provide the best animal care possible. Whether food or pharmaceuticals, Neogen's provides a one-stop shop for the health and safety to our animals and our customers operations.

Neogen's culture combines stability with a deep belief in providing professional and personal growth. Our Pillars of Trust - the principles that guide our everyday decision-making, include Openness, Honesty, Credibility, Respect, and Service. It's our belief in these characteristics that provides a consistent, happy and healthy work environment for our employees.

Title: Project Manager
Location: Summit, NJ
Start date: ASAP
Responsibilities:This position will support Quality Control (QC) in project management for the CELabs LIMS and SMART QC systems.
The role will report to the global QC Systems and Services function.
The Project Manager will develop project plans, develop, and manage timelines, identify, and respond to critical path barriers.
The role will require significant collaboration across internal and external functions to ensure on time release of final product. Ideal candidate will have demonstrated ability to balance multiple competing priorities, manage projects.
The role is required to work in a cross functional and dynamic setting where project assumptions and scenarios may change and therefore requires an individual who can quickly adapt to the changes and manage communications at different levels in the organization.
Work scope will include operations excellence, continuous improvement projects and capacity expansion projects in support of commercial and clinical QC.
This role will work with project management and subject matter experts across multiple sites including Manufacturing, Operational Excellence, Supply Chain, MS&T, Quality Assurance, Quality Control, Process Development, CMC, TT lead, TCT lead, Global Engineering, Facilities Engineering, PMO, IT, EHS, Finance, Regulatory, and Clinical and Commercial Operations.
Manage multiple, low to medium complexity process improvement and or Technical projects and timelines.
Effectively manage team meetings, including the scheduling of meetings, the preparation of agendas, the development of meeting minutes, and the follow up on action items.
Serve as a member of sub-teams, tracking timelines elements to ensure that functional deliverables are completed on time and according to relevant quality standards
Develop critical path analyses with the team to understand risks and opportunities within project timelines and help develop contingency plans
Responsible for the preparation of routine status reports and communicate project progress to stakeholders
Lead operational projects including weekly QC LIMS huddles, QC CTDO LIMS planning and management and monitoring tools
Ensure that team recommendations related to project direction and timelines which need endorsement by governance teams are planned for review at appropriate milestones
Promote a culture of collaboration, cooperation, execution excellence, effective communication, and cross functional problem-solving to enable a high performing team.
Develop and implement KPI and reporting capabilities
Collaborate with IT Business Partners in support of modeling, scheduling simulation implementations and automated scheduling tools

Requirements:Bachelors Degree required
5 plus years relevant work experience required, preferably in a regulated pharmaceutical manufacturing environment.
An equivalent combination of education, experience and training may substitute.
Preferred but not required:
PMP certification desirable.
Experience in biopharmaceutical clinical, supply chain, manufacturing, and commercialization.
Ability to work independently
Ability to matrix manage cross functional teams
Must be competent in Project Management tools and methodologies
Excellent organizational and time management skills
Experience with regulated GMP environment for manufacturing (Biologics or Cell Therapy experience is a plus).
Strong analytical, problem-solving, and critical thinking skills
High attention to detail skills
High organization skills with ability to multi task several objectives in parallel
People and project management skills
Advanced proficiency in MS Office applications
Proficient written and verbal communication skills
Ability to develop and provide training on various functions

Job Description: PURPOSE AND SCOPE OF POSITION:
This position will support Quality Control (QC) in project management for the CELabs LIMS and SMART QC systems. The role will report to the global QC Systems and Services function. The Project Manager will develop project plans, develop, and manage timelines, identify, and respond to critical path barriers. The role will require significant collaboration across internal and external functions to ensure on-time release of final product. Ideal candidate will have demonstrated ability to balance multiple competing priorities, manage projects. The role is required to work in a cross-functional and dynamic setting where project assumptions and scenarios may change and therefore requires an individual who can quickly adapt to the changes and manage communications at different levels in the organization.
Work scope will include operations excellence, continuous improvement projects and capacity expansion projects in support of commercial and clinical QC. This role will work with project management and subject matter experts across multiple sites including Manufacturing, Operational Excellence, Supply Chain, MS&T, Quality Assurance, Quality Control, Process Development, CMC, TT lead, TCT lead, Global Engineering, Facilities Engineering, PMO, IT, EHS, Finance, Regulatory, and Clinical and Commercial Operations.

REQUIRED COMPETENCIES:
Knowledge, Skills, and Abilities:
•Ability to work independently
•Ability to matrix manage cross functional teams
•Must be competent in Project Management tools and methodologies
•Excellent organizational and time management skills
•Experience with regulated GMP environment for manufacturing (Biologics or Cell Therapy experience is a plus).
•Strong analytical, problem-solving, and critical thinking skills
•High attention to detail skills
•High organization skills with ability to multi-task several objectives in parallel
•People and project management skills
•Advanced proficiency in MS Office applications
•Proficient written and verbal communication skills
•Ability to develop and provide training on various functions

Education and Experience:
•Bachelor's degree required
•5 years relevant work experience required, preferably in a regulated pharmaceutical manufacturing environment.
•An equivalent combination of education, experience and training may substitute.
Preferred but not required:
•PMP certification desirable.
•Experience in biopharmaceutical clinical, supply chain, manufacturing, and commercialization.

DUTIES AND RESPONSIBILITIES:
•Manage multiple, low to medium complexity process improvement and/or Technical projects and timelines.
•Effectively manage team meetings, including the scheduling of meetings, the preparation of agendas, the development of meeting minutes, and the follow up on action items.
•Serve as a member of sub-teams, tracking timelines elements to ensure that functional deliverables are completed on time and according to relevant quality standards
•Develop critical path analyses with the team to understand risks and opportunities within project timelines and help develop contingency plans
•Responsible for the preparation of routine status reports and communicate project progress to stakeholders
•Lead operational projects including weekly QC LIMS huddles, QC CTDO LIMS planning and management and monitoring tools
•Ensure that team recommendations related to project direction and timelines which need endorsement by governance teams are planned for review at appropriate milestones
•Promote a culture of collaboration, cooperation, execution excellence, effective communication, and cross-functional problem-solving to enable a high-performing team.
•Develop and implement KPI and reporting capabilities
•Collaborate with IT Business Partners in support of modeling, scheduling simulation implementations and automated scheduling tools
dditional Job Requirements:
None