Quality Supervisor, Complaints

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 Complaints Quality Supervisor has the primary function of supervising the team that was conducting customer complaint investigations. The individual also performs support functions related to maintaining the overall Quality Management System.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Supervise the team involved in the intake, drafting, and closure of customer complaints
• Collaborate with internal departments to effectively communicate with other customers
• Capable of resolving complex issues through collaboration with internal and external parties
• Represent PCI on customer calls related to customer complaint investigation
• Receive communications from customers related to complaints
• Log complaints into the QMS system
• Conduct investigations utilizing root cause analysis tools and work with other functional areas to identify the cause and appropriate corrective and preventive actions
• Draft and peer review customer complaint investigations
• Communicate directly with clients in resolution of customer complaints
• Compile metrics for the functional area
• Assist with compiling information for regulatory filings
• Responsibility will include some facets of maintaining and improving the overall Quality Management Systems (i.e. APQRs, internal audits, CAPA effectiveness, change control)

SUPERVISORY RESPONSIBILITIES:

Supervisory responsibilities: 3 to 6 individuals

QUALIFICATIONS:

Required

• Supervisory experience is required for the role. Team size 3-6 and growing.

• Experience with Quality Management Systems (i.e. APQRs, internal audits, CAPA effectiveness, change control)

• Bachelor's Degree in a related field (Scientific) and/or 1-5 years related experience and/or training.
• Prior experience in technical writing and utilizing root cause analysis tools is required
• The candidate must be able to demonstrate basic proficiency with personal computers, business software (e.g., MS Office) and technical software (e.g., TrackWise). Ability to create, use and interpret scientific tables, charts, and graphs.
• Possesses excellent organizational, time management and multi-tasking skills to meet commitments and deadlines.
• Problem solving skills along with a strong collaborative approach is required.

• Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
• High Reasoning: Ability to solve practical problems and deal with a variety of concrete variables in situations where there is only limited standardization.

Preferred

• Lean Six Sigma or process improvement experience
• Ability to effectively present information to various people as the job requires.
• Ability to identify and resolve problems in a timely manner.
• Ability to show success in managing employees.

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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.