Manager, Quality Assurance – ADD

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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.

Summary of Objective:

Overall responsibility for the ADD Complaints and Investigations team. Helps drive project success to provide PCI a competitive advantage in long–term quality customer management and maintaining GMP compliance and system improvement. This role involves supervision of 1–8 individuals who write customer complaint responses and investigations and participate in improvement projects. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; and addressing complaints and resolving problems.

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 are the following, but other duties may be assigned.

Accountable for overall management, reviewing, planning, and administering of resource allocation and workload planning for the ADD Complaints and Investigations team staff reporting directly.

Responsible for direct supervision and personnel development, including training and mentoring of direct reports.

Oversee Complaint and Investigation Quality Metrics.

Guide on performing complaint investigations and deviations, and ensure on-time completion of investigation reports in accordance with Customer requirements.

Review, respond to, and resolve all inquiries, requests, and issues associated with consumer complaints.

Primary reviewer and approver of complaint responses and investigations.

Upkeep of Excel safe ADD complaint and investigation trending spreadsheets, and assistance with validation of Excel safe worksheets when needed.

Oversee and write/revise SOPs/WPs in the E-Doc system related to ADD complaints and investigations.

Responsible for the administration, implementation, and project management of assigned special projects, including using standardized methodology.

Interpret technical specifications, product requirements, and design concepts for components, assemblies, and products to identify opportunities and develop recommendations to improve product and process design.

Analyze metrics for trends, identify root causes, and implement actions to mitigate negative trends.

Statistical assessment of complaint/investigation-related data to drive improvements.

Analyze customer and business needs in the determination of the Complaint and Investigations team strategies.

Lead or participate in Quality optimization teams (i.e., lean, streamline, efficiencies, etc.).

Work closely with internal departments to partner on projects as needed, working to identify trends and process gaps and assisting in the implementation of corrective/preventive actions and process improvements.

Participate as a representative for Customer quarterly review meetings when required.

Participate in customer audits.

Participate in internal audits.

Participate in Regulatory audits.

Oversee and present quality-related metrics and key performance indicators for the team’s performance.

Oversee the coordination quality activities of the team to ensure that the goals and objectives of the team are accomplished.

This position may require overtime and/or weekend work.

Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, and rules.

Attendance at work is an essential function of this position.

Performs other duties as assigned by the Manager.

Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

Required:

• Bachelor’s Degree in a related field and/or 5-10 years related experience and/or training.
• College-Level Mathematical Skills
• Intermediate Computer Skills: Ability to perform more complex computer tasks and have knowledge of various computer programs.
• Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
• Very High Reasoning: Ability to define problems, collect data, establish facts, and draw valid conclusions. Be able to interpret an extensive variety of technical instructions in math or diagram form and deal with several abstract/concrete variables.

• High Standard of Report Writing

• Statistical knowledge and applied experience.

Preferred

Ability to set and achieve challenging goals.

Ability to demonstrate attention to detail.

Ability to exhibit sound and accurate judgment.

Ability to follow instructions and respond to management direction.

Ability to identify and resolve problems on time.

Ability to display excellent time management skills.

Ability to adapt to changing work environments.

Ability to work independently and/or as part of a team.

For candidates in Illinois: This position’s base salary hiring rangeis $86,880-$97,740, plus a 10% MBP annual performance bonus eligibility. Final offer amounts are determined by multiple factors, including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k.

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Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future

Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.

LSNE is an EEO/AA Employer and all qualified applicants will receive consideration for employment without regard to, their race, color, religion, sex, age, national origin, ancestry, sexual orientation, gender identity, disability, protected genetic information, protected veteran status, military service, or other protected status. The Company’s EEO policy, as well as its affirmative action obligations, include the full and complete support of The Company.

 

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