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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.

We are now looking for a Director of Quality Operations PCI Ireland to join our team.

Primary Responsibilities:

• Full ownership and accountability for the Management of Quality Operations at PCI Ireland site(s) in line with company strategy and within Regulatory requirements.

• Main point of Contact for all Quality escalations from Customers

• Ensuring adequately resourced Quality Operations Department with clear roles and responsibilities defined.

• Develop and monitor the annual budget for the department.

• 3 Buildings currently in scope.

Routine Operations:

• To ensure that products are packaged and controlled to meet the requisite safety and quality and GMP standards.

• To ensure that there is a system in place for the following :

• All incoming materials to be used for Packaging are controlled, released and issued in a timely/prescribed manner to Operations.

• Batch Record/Packaging instructions are designed appropriately and suitable for operation performed.

• Review completed documentation, addressing any customer queries

• Tracking and monitoring of documentation throughput times.

• Quality Operations metrics are in place, are measured and maintained and are in line with Company targets.

• To act as the main focal point for Quality Operations related matters at all PCI Dublin facilities.

• Acting as a key contact with customers and auditors.

• Manage the Quality Operations function

Quality Operations QMS:

• Ensuring the team support the maintenance of complaints, change controls, deviations and CAPA’s as required.

• Provide governance, guidance, and support for the various elements, such as:

• Audits

• Training

• SOPS

• Documentation (BPRs, Protocols)

• Change control (MOC),

• Complaints,

• Investigations (Events & Deviations)

• Root cause Analysis

• CAPAs

• GEMBA walks

• Logbook reviews

• Customer Meetings and product support

• Delivering the quarterly reports for senior management.

• Ensure all process documentation is fully auditable i.e., that it is prepared, updated, and filed in accordance with all regulatory expectations.

General

• Develop and sustain an environment of continuous improvement through active implementation of process excellence and lean methodologies.

• Actively promote best practice in quality methods and continuous improvement.

• Problem solving.

• Benchmarking processes for Quality Operations

• Provide project management leadership to ensure effective planning and timely execution of all processes.

• Any other duties required by Line Manager.

Secondary Responsibilities:

All employees are required to satisfactorily perform the essential duties and responsibilities of their position. The essential duties and responsibilities listed above are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this job.

REQUIREMENTS

• Bachelor's degree in Science, Engineering, Technology or a related discipline.

• Experience of leading audits with customers

• Experience working within a Pharmaceutical Environment.

• Industry knowledge of the requirements of EU GMP (HPRA/FDA).

• Strong organisational / time management skills.

• Effective interpersonal communications and management skills.

• Flexibility to travel between all PCI Ireland Pharma Sites.

• Experience of working at management level within a similar environment an advantage.

• High motivation, flexibility and the ability to work on own initiative.

• At least 7-10 years’ experience in a quality management role in the Pharma industry.

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Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future (https://pci.com/)

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.

Why work for PCI Pharma Services?

At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don’t say no, we figure out how.

PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled