Project Manager, Quality Control

Posted 8 Days Ago
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Rochester, MI
Senior level
Healthtech • Pharmaceutical • Telehealth
The Role
The QC Project Manager oversees project planning and execution, manages timelines and budgets, resolves issues, and communicates with stakeholders to ensure project success.
Summary Generated by Built In

Why Endo?

We want the best and brightest people at Endo to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life.

Job Description Summary

Reporting to the Sr Manager, Quality Control, the Project Manager identifies and circulates the project goals, objectives, and scope of all assigned projects. The QC Project Manager then creates a project plan that outlines the specific tasks, timelines, and resources required for each project. They also lead the communication between the project team and stakeholders, manage risks and issues, and monitor progress to ensure that the project stays on track. This role acts as the right-hand partner to the Sr Manager, Quality Control, providing feedback, updates and representing them as needed and appropriate throughout the organization.

Job Description

Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority (capital, operating, etc.), P&L responsibility, etc.

Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time

Accountability

Responsibilities

% of Time

  • In charge of planning, budgeting, monitoring, and reporting each assigned project with the use of formal project management methodologies, such as Lean Six Sigma. They may be required, from time to time, to pitch the idea of the project and lead it until its fruition.  
  • Establishing deadlines and monitoring projects' progress:
    • The QC Project Manager plans and develops project roadmaps.
    • Must constantly scrutinize how the project is moving forward. 
    • Manage the project cycle from developing an accurate timeline of project completion to ensuring activities get completed within the assignment's parameters. 
    • Foresee delays and inform the team and stakeholders of any adjustments needed.
  • Identify and resolve project issues and elevate any critical roadblocks for quick problem-solving.  
  • Collaboration:
    • Ensure collaboration, negotiation, and satisfaction with all stakeholders.
    • Act as a bridge between upper management and the team who is responsible for the execution of the project.
    • Responsible for bringing together and managing the project's team to create a well-oiled project machine.
    • Set up the project team for success by providing (or securing) guidelines, direction, and training when needed. 
  • Managing the project's and department's financial resources, including headcount, equipment, and any other financial-related expenses. 
  • Responsible for evaluating the performance of all projects assigned, including:
    • Ensuring the project runs smoothly.
    • Staying on schedule or negotiating new deadlines.
    • Providing updates on the progress of the project regularly.

Total

100%

Qualifications

Education & Experience

Minimal acceptable level of education, work experience, and certifications required for the job

  • Bachelor of Science degree in science or related field.
  • 5+ years of previous quality laboratory experience in a fast-paced regulated manufacturing environment required.
  • Prior experience working in a cGMP/GLP environment required.
  • Project Management Professional (PMP) or Lean certification is preferred.

Knowledge

Proficiency in a body of information required for the job    e.g., knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.

  • Risk management: Able to identify potential risks and take measures to mitigate them before they can negatively impact the project.
  • Budget management: They need to be able to manage project budgets and make informed decisions to ensure the project stays within budget.
  • Problem-solving: They must quickly identify and solve problems that may arise during a project. Must possess critical thinking capabilities.
  • Continuous Improvement: Work with multiple improvement strategies such as Six Sigma and Total Quality Management to develop and monitor improvement processes within their organization.
  • Technical expertise: They must have a good understanding of the technical aspects of the project and be able to communicate effectively with technical team members.

Skills

&

Abilities

Often referred to as “competencies”, leadership attributes, skills, abilities, or behaviors that may be enterprise, functional or job specific     e.g., coaching, negotiation, calibration, technical writing etc.

  • Communication: Superb communication skills to convey ideas, expectations, and information to the team, stakeholders, and senior management.
  • Leadership: Must be able to lead a team of peers to success by ensuring there is clear direction, motivation, and support.
  • Organization: Must be highly organized to manage multiple tasks, timelines, and resources.
  • Self-management: Able to prioritize tasks and manage themselves effectively to ensure deadlines are met.
  • Adaptability: They must be adaptable and adjust plans and strategies to keep the project on track.
  • Teamwork: They must be able to work collaboratively with their team to achieve project goals.
  • Political Savvy:  They must have the ability to exhibit confidence and professional diplomacy while effectively relating to people at all levels, internally and externally.
  • Confidentiality: They must have the ability to always maintain absolute confidentiality in all situations.
  • Communication: Capable of clearly communicating in the appropriate detail for the intended recipient and purpose concepts, objectives, rationale, methodologies and intent to the project team members, stakeholders, and senior management sponsors.
  • Leadership: Is a competent and capable situational leader and project leader, providing direction, motivation, oversight, coaching and feedback to peers and teammates that are not direct reports. Demonstrates the behaviors that reflect endo’s values of Integrity & Quality, Collaboration, Drive, Innovation and Empathy.
  • Critical Thinking: Applies structured data and risk analysis and critical thinking in all elements of their role and is capable of coaching the development and use of these skills in others. 
  • Organization: Must be highly organized to manage multiple tasks, timelines, and resources. Able to prioritize tasks and manage themselves effectively to ensure deadlines are met.
  • Adaptability: They must be adaptable and adjust plans and strategies to keep the project on track.
  • Teamwork: They must be able to work collaboratively with their team to achieve project goals.

Physical Requirements

Physical & mental requirements     e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.

Disclaimer:  The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications.  Management reserves the right to change or modify such duties as required.

EEO Statement:

At Endo, we firmly believe in the principles of equal employment opportunity and strive to create an atmosphere where all employees, regardless of their race, color, creed, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability (including pregnancy), age, or military or veteran status, feel valued, respected, and empowered. Our commitment to EEO extends to every aspect of employment, including recruitment, hiring, training, promotions, compensation, benefits, transfers, terminations, and all other employment practices. We are dedicated to ensuring that all employment decisions are based on qualifications, skills, and merit.

Top Skills

Lean Six Sigma
Project Management Professional
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The Company
Montreal, Quebec
1,722 Employees
On-site Workplace
Year Founded: 1997

What We Do

At Endo, our far-reaching vision is simple: to help everyone we serve live their best life. As a specialty pharmaceutical company, we’re motivated by a strong sense of purpose to find better ways to meet unique medical needs.

Our global team of passionate employees understands the importance of their work. We’re dedicated to supporting one another as we connect with communities and foster partnerships that elevate quality-of-life and bring the best treatments forward.

Our uncompromising commitment results in the delivery of life-enhancing therapies. From intelligent product selection to commercialization, we strive to make a meaningful, tangible impact to help everyone live their best life.

Endo has global headquarters in Malvern, Pennsylvania.

Community Guidelines:
1. Be respectful. Everyone who visits our page should feel comfortable and respected.
2. If we see a comment that violates anything in the following list, it may be removed.
• Comments that use profanity; personally attack or bully another individual; or are off-topic, misleading, factually inaccurate, political, spam, defamatory, discriminatory or promotional.
• Comments that are excessively repetitive and/or disruptive to the community.
• Comments that promote illegal activity, use copyrights or trademarks or are related to an ongoing legal matter.
• Comments that appear to be medical advice.
We reserve the right to remove a reply for any reason at any time.
3. Adverse Event Reporting: If we see a post about an adverse event, an Endo representative will need to contact you to find out more information to comply with regulatory guidelines. If you experience a side effect while using an Endo product, please consult your physician or pharmacist immediately. You may also report to the FDA at fda.gov/medwatch or 800-FDA-1088.

Replies from other users do not necessarily reflect the views of Endo. We do not endorse content added by other users.

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