Manager, Quality Operations

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:

Responsible for managing daily operations of the IQA Receiving and Quality Operations Departments through the activities of the Supervisors, Leads, Auditors and Inspectors. Responsible for the quality issues/events that occur on all shifts.

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.

• Provide knowledge, training, leadership, motivation, and guidance to ensure staff have a clear understanding of tasks, responsibilities, business goals and customer demands.
• Provide 24-hour support for Quality related issues either by phone or email.
• Be observant of processes, performance, and behaviors, focusing on continuous improvement.
• Manage budgets and plans for business growth.
• Compile, analyze and report key departmental Quality metrics (Product HOLDs, Line Clearance Observations/Failures, Near Miss events and Right First-Time metrics).
• Provide support via emails, phone, Quarterly Business Review/meetings, tours, audits, and investigations.
• Facilitate Annual Product Reviews. Deliver customer satisfaction.
• Perform and participate in tours of functional areas for internal, customer and regulatory audits. Identify risks, observations, and controls. Communicate results and develop action plans to resolve issues.
• Provide training and presentations to all associates as needed.
• Ensure headcount, staff and production demands are met.
• Ensure Quality issues are resolved appropriately and report results to Quality and Production Management.
• Responsible for developing, review and approve department Change Controls for Standard Operating Procedures, Job Aids, Batch Records, Material Specifications and Forms.
• Responsible for facilitating troubleshooting issues for the department’s testing equipment and or work with vendors to resolve errors.
• Collaborate with Project Management for New Product Development; ensuring batch record documentation and product launches are successful.
• Oversee incoming, in-process and finished goods inspections of products to ensure conformance to established standards.
• Investigate root causes of quality events/defects and recommending solutions.
• Oversee functions of Incoming Quality Inspection and Quality Operations.
• Manage non-conforming products, materials, and reports (NMRs, Product HOLDs, Line Clearance Failures).
• Manage Batch Record Right First-Time program.
• Ensure compliance for onboarding and training new Quality team members.
• Ability to partner and collaborate with functional departments.
• Order and or approve supply requisitions.
• Oversee Pest Control Program.
• Oversee Mean Kinetic Temperature and Environmental Monitoring.Primary Quality Contact for Business Units regarding operational issues.
• Oversee retention of PCI, customer retain samples (retain cage) and outbound retain shipments.
• Provide hands-on training ensuring employees are trained to quality functions. 
• Prepare periodic and special reports concerning departmental activities, problems, quality systems, schedules, etc.
• Lead and drive improvement / harmonization initiatives across multiple facilities.
• Ensure Performance Metrics (Safety/Quality/Regulatory/Delivery), goals and objectives are on track for completion.
• Report and escalate to Senior Management of any potential risks that impact Quality.
• This position may require overtime and/or weekend work.
• Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.
• Attendance at work is an essential function of this position.
• Performs other duties as assigned by Manager.

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.

Required:

• Bachelor's Degree in a related field and/or 1-5 years related experience and/or training.
• College Level Mathematical Skills.
• Intermediate Computer Skills: Ability to perform more complex computer tasks and has 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.

Preferred:

• Ability to effectively present information to various people as the job requires.

• Ability to display a willingness to make decisions.

• Ability to display excellent time management skills.
• Ability to work independently and/or as part of a team.

The hiring range for this position is $86,880 - $97,740 annually plus eligibility for an annual performance bonus. 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.