Know ATS Score
CV/Résumé Score
  • Expertini Resume Scoring: Our Semantic Matching Algorithm evaluates your CV/Résumé before you apply for this job role: Sr. QA Manager.
United States Jobs Expertini

Urgent! Sr. QA Manager Job Opening In Madison – Now Hiring PCI Pharma Services



Job description

Life changing therapies.

Global impact.

Bridge to thousands of biopharma companies and their patients.


We are PCI.


Our investment is in People who make an impact, drive progress and create a better tomorrow.

Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

The Senior QA Manager will work with other departments to ensure the quality of products and compliance to internal procedures and external standards.

The role supports and provides quality oversight of the day-to-day operations of the Madison, WI based drug manufacturing facility.

In this role, the opportunity exists for the incumbent to shape and transform GxP programs by providing QA expertise and guidance to lead product candidates and pipeline assets.

The incumbent will also be a key member of a cross functional team focused on harmonization and improvement of quality systems and processes across all PCI WI GMP locations.

Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

The essential duties and responsibilities include the following but other duties may be assigned.

  • Provides quality oversight of manufacturing activities on a day-to-day basis.
  • Review, develop, and improve quality system procedures, specifications, and test methods.
  • Provide status reports, including relevant quality metrics and participates in the management review process.
  • Establish collaborative relationships with internal and external customers to ensure all quality and compliance matters and any issues that arise are addressed in an open and timely manner.
  • Monitor, identify, and propose quality process/system improvements and provides strategic foresight to identify and implement changes to enhance long term goals of the department and drive continuous improvement.
  • Serve as QA representative to cross functional project teams such as process improvement.
  • Perform risk assessments to comply with internal procedures and external guidelines.
  • Initiate, revise, and review controlled cGMP documents including SOPs, Material Specifications, Investigation protocols/reports, validation protocols/reports as applicable.
  • Ensures site readiness for regulatory inspections, client audits, and internal audits.
  • Perform review of raw material documentation for release of internal and external clinical products/commercial products, while ensuring compliance with cGMPs, site SOPs, and regulatory requirements.

    Prioritize record review in support of business needs including maintaining batch status and communicate release needs throughout the organization.
  • Assist with internal audits, client audits as well as supplier audits as needed.

    Review and approve supplier documents requiring Quality approval.
  • Interface with internal and external customers to address any documentation and compliance concerns.
  • Provides oversight to Quality walkthroughs for Shutdown and Inspection Readiness activities and ensures compliance with site and corporate procedures.
  • Establish and communicate performance objectives for Quality Assurance staff that are consistent with the business’s unit goals, Quality and Technical Operations objectives.

    Defines and enforces performance measures, provides developmental feedback and coaching and creates a collaborative environment enhances unit performance and integration across site departments.
  • May provide Quality review and approval of investigations, deviations, events, change controls and CAPAs.
  • Hires, integrates, and develops high quality talent, capable of delivering against the department's goals and objectives.
  • Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position.

    Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

    EDUCATION AND PROFESSIONAL EXPERIENCE

  • Knowledge of science generally attained through studies resulting in a BS degree in Science, Engineering, Biochemistry or related discipline, or its equivalent is required.

    ASQ certification preferred.

    ASQ certification preferred.
  • Minimum of 8 years of pharmaceutical or biotech industry experience with 2+ years of experience in a QA Operations role supporting late stage clinical and/or commercial production.

    Minimum of 2 years of management responsibility preferred.
  • A minimum of 8 years of overall experience in biopharmaceutical quality
  • Knowledge of biotech bulk and finished product manufacturing, Drug Substance or Drug Product disposition and batch record review is highly desirable.
  • Experience performing RCA, technical writing, and working with quality related investigations.
  • Knowledge of laboratory and production equipment and IQ/OQ/PQ
  • Knowledge of US and EU cGMP regulations and guidance
  • Experience using Risk Management Tools (FMEA, HACCP, PHA, etc.) and familiarity with ICH Q9.
  • Background and demonstrated effectiveness in quality assurance operations and compliance of commercial biologics manufacturing with oversight of final product release.
  • Knowledge in Operational Excellence and Continuous Improvement is highly desirable.
  • Experience in building and growing an organization into a high-performance team.
  • Knowledge of electronic systems including any of the following Master Control, or electronic batch recording systems, is desirable.

    Microsoft Office suite knowledge and proficiency with Excel is desirable.
  • PERSONAL SKILLS & COMPETENCIES

  • Exceptional organizational skills
  • Ability to make risk-based decisions and resolve issues with minimal guidance.
  • Excellent interpersonal skills and the ability to communicate well orally and in writing.
  • Proficiency in MS Office including Word, Excel, Access, and Visio
  • Ability to lead people in a dynamic, fast-paced work environment.
  • Honesty, integrity, respect, and courtesy with all colleagues
  • Creative with the ability to work with minimal supervision and balanced with independent thinking.
  • Resilient through operational and organizational change
  • Demonstrated leadership, interpersonal, communication, and motivation skills.
  • Well-practiced in exercising sound judgment in decision-making
  • Demonstrated multitasking and organization skills.
  • Past experience where one was required to work in a team-based environment with a diverse group of people.

    Previous work responsibility, which required a high degree of attention to detail.
  • #LI-LL1

    Join us and be part of building the bridge between life changing therapies and patients.


    Required Skill Profession

    Operations Specialties Managers



    Your Complete Job Search Toolkit

    ✨ Smart • Intelligent • Private • Secure

    Start Using Our Tools

    Join thousands of professionals who've advanced their careers with our platform

    Rate or Report This Job
    If you feel this job is inaccurate or spam kindly report to us using below form.
    Please Note: This is NOT a job application form.


      Unlock Your Sr QA Potential: Insight & Career Growth Guide


    • Real-time Sr QA Jobs Trends in Madison, United States (Graphical Representation)

      Explore profound insights with Expertini's real-time, in-depth analysis, showcased through the graph below. This graph displays the job market trends for Sr QA in Madison, United States using a bar chart to represent the number of jobs available and a trend line to illustrate the trend over time. Specifically, the graph shows 55484 jobs in United States and 249 jobs in Madison. This comprehensive analysis highlights market share and opportunities for professionals in Sr QA roles. These dynamic trends provide a better understanding of the job market landscape in these regions.

    • Are You Looking for Sr. QA Manager Job?

      Great news! is currently hiring and seeking a Sr. QA Manager to join their team. Feel free to download the job details.

      Wait no longer! Are you also interested in exploring similar jobs? Search now: .

    • The Work Culture

      An organization's rules and standards set how people should be treated in the office and how different situations should be handled. The work culture at PCI Pharma Services adheres to the cultural norms as outlined by Expertini.

      The fundamental ethical values are:
      • 1. Independence
      • 2. Loyalty
      • 3. Impartiality
      • 4. Integrity
      • 5. Accountability
      • 6. Respect for human rights
      • 7. Obeying United States laws and regulations
    • What Is the Average Salary Range for Sr. QA Manager Positions?

      The average salary range for a varies, but the pay scale is rated "Standard" in Madison. Salary levels may vary depending on your industry, experience, and skills. It's essential to research and negotiate effectively. We advise reading the full job specification before proceeding with the application to understand the salary package.

    • What Are the Key Qualifications for Sr. QA Manager?

      Key qualifications for Sr. QA Manager typically include Operations Specialties Managers and a list of qualifications and expertise as mentioned in the job specification. Be sure to check the specific job listing for detailed requirements and qualifications.

    • How Can I Improve My Chances of Getting Hired for Sr. QA Manager?

      To improve your chances of getting hired for Sr. QA Manager, consider enhancing your skills. Check your CV/Résumé Score with our free Tool. We have an in-built Resume Scoring tool that gives you the matching score for each job based on your CV/Résumé once it is uploaded. This can help you align your CV/Résumé according to the job requirements and enhance your skills if needed.

    • Interview Tips for Sr. QA Manager Job Success
      PCI Pharma Services interview tips for Sr. QA Manager

      Here are some tips to help you prepare for and ace your job interview:

      Before the Interview:
      • Research: Learn about the PCI Pharma Services's mission, values, products, and the specific job requirements and get further information about
      • Other Openings
      • Practice: Prepare answers to common interview questions and rehearse using the STAR method (Situation, Task, Action, Result) to showcase your skills and experiences.
      • Dress Professionally: Choose attire appropriate for the company culture.
      • Prepare Questions: Show your interest by having thoughtful questions for the interviewer.
      • Plan Your Commute: Allow ample time to arrive on time and avoid feeling rushed.
      During the Interview:
      • Be Punctual: Arrive on time to demonstrate professionalism and respect.
      • Make a Great First Impression: Greet the interviewer with a handshake, smile, and eye contact.
      • Confidence and Enthusiasm: Project a positive attitude and show your genuine interest in the opportunity.
      • Answer Thoughtfully: Listen carefully, take a moment to formulate clear and concise responses. Highlight relevant skills and experiences using the STAR method.
      • Ask Prepared Questions: Demonstrate curiosity and engagement with the role and company.
      • Follow Up: Send a thank-you email to the interviewer within 24 hours.
      Additional Tips:
      • Be Yourself: Let your personality shine through while maintaining professionalism.
      • Be Honest: Don't exaggerate your skills or experience.
      • Be Positive: Focus on your strengths and accomplishments.
      • Body Language: Maintain good posture, avoid fidgeting, and make eye contact.
      • Turn Off Phone: Avoid distractions during the interview.
      Final Thought:

      To prepare for your Sr. QA Manager interview at PCI Pharma Services, research the company, understand the job requirements, and practice common interview questions.

      Highlight your leadership skills, achievements, and strategic thinking abilities. Be prepared to discuss your experience with HR, including your approach to meeting targets as a team player. Additionally, review the PCI Pharma Services's products or services and be prepared to discuss how you can contribute to their success.

      By following these tips, you can increase your chances of making a positive impression and landing the job!

    • How to Set Up Job Alerts for Sr. QA Manager Positions

      Setting up job alerts for Sr. QA Manager is easy with United States Jobs Expertini. Simply visit our job alerts page here, enter your preferred job title and location, and choose how often you want to receive notifications. You'll get the latest job openings sent directly to your email for FREE!