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Job description

SUMMARY

Responsible for the alignment of quality initiatives throughout Pelican BioThermal organization’s strategic goals. Will focus on developing the culture of the Pelican BioThermal Quality Management System (QMS) Product & Services to ensure continual improvement and that offerings satisfy or exceed our customers’ expectations. Is responsible for ensuring that Pelican BioThermal overall development and implementation of quality processes and systems are aligned with corporate quality goals

PRIMARY DUTIES AND RESPONSIBILITIES

• Establishes and maintains the Pelican BioThermal Quality vision, mission, and strategy.
• Manages and provides leadership to Quality teams including Quality Assurance, Quality Systems, and Quality Control departments for Pelican BioThermal.
• Leads Quality Assurance oversight of product release, documents and records control, production and services, approval of process deviations, change management controls, compliance, and investigations.
• Leads Quality Systems Management including the Quality Compliance, in-house compliance systems and audits as well as Client and Supplier audits. Maintains and executes to an up-to-date knowledge base for the QMS (should include: cGMP, ISO, client compliance requirements).
• Leads Quality Engineering operations including Validation, Technical Operations, Technical Troubleshooting, and CAPA.
• Oversees Quality Risk Management activities.
• Drives technical troubleshooting, operational improvements, and efficiency improvements while working within cGMP and global regulatory compliance.
• Serves as the Management Representative to ensure the processes need for the quality management system are established, implemented, and maintained; and acts as the liaison to external bodies/agencies for the purposes of achieving and maintaining certifications.
• Hosts ISO re-certification and any regulatory inspections, leads inspection readiness activities, and manages responses and closure of inspection findings.
• Establishes and maintains Pelican BioThermal KPI’s and Customer Satisfaction metrics.
• Ensures that the Closed Loop Corrective Action and Customer Complaint processes are established and integrated throughout Pelican BioThermal – Examples: a) Complaints/feedback system and b) single source point-of-contact for customers with quality concerns regarding products and services.
• Develops a unified approach to and application of Environmental Quality Management System (EQMS) to ensure compliance in all our major markets and eliminates redundancies.
• Actively participates in new product development cycles to ensure customer and defined requirements are achieved.
• Implements new product release controls for critical quality issues and ensures the Voice of the Customer (VOC) is considered (i.e. implementation of change management to comply with and meet pharma industry standards)
• Establishes, sustains and improves the Warranty and Repair policies for all products and services.
• Together with Sourcing, identifies and engages key vendors that are crucial to the success of the Pelican group and monitors their progress and performance improvements (i.e. Supplier metrics and scorecard).
• Sets appropriate goals and targets to ensure that key performance indicators are being satisfied; assists any and all Pelican BioThermal departments to develop meaningful quality systems, metrics and methods.
• Responsible for overall training and development initiatives for quality assurance and quality control staff, coaches and counsels direct reports in their performance and professional development, and has overall authority for approving pay increases, hiring decisions and disciplinary actions.
• Actively supports Pelican’s commitment to Quality and all quality objectives, with an emphasis on continual improvement.
• Follows company policies and practices as outlined in the Employee Handbook and/or applicable employment agreement. Follows safety guidelines and procedures in accordance to the job.
• Perform special projects and additional duties as assigned by the President.

OB REQUIREMENTS

• In-depth knowledge of quality assurance processes with B.S. in Quality Engineering or equivalent, 7+ years in a managerial capacity with department level budget line responsibility
• Must have excellent analytical and organizational skills, be detail-oriented and able to work under minimum supervision.
• Must have excellent written, negotiation, presentation and verbal communication skills & be proficient in Word, Excel, MS Project and/or other appropriate software.
• Must have the ability to complete assignments within both the time frame and budget specified
• Must demonstrate solid judgment, accomplish goals and champion ethical business practices at all times.
• Must demonstrate leadership skills and interact effectively and cooperatively with employees, with a demonstrated ability to bring together virtual teams and build consensus at all levels of the organization.
• Must be a self-motivated, proactive, focused high-achiever who consistently delivers results and has the ability to make rapid adjustments in response to industry changes.
• Demonstrated success recruiting, building, developing, coaching and retaining a highly motivated, synchronized Quality Assurance team with a sense of urgency and a drive to excel.
• Must be flexible with work schedules and be available to work overtime on evenings and weekends, with or without advanced notice.
• Must be able to operate in a fast-paced organization and handle multiple projects simultaneously.
• Must be able to travel locally and internationally.

ADDITIONAL INFORMATION:

• Actively supports and complies with Peli’s objectives, guidelines and commitment to Quality and Safety, with an emphasis on continual improvement.
• Must be able to interact effectively and cooperatively with employees at all levels.
• Must have the ability to complete assignments within the timeframe specified by the Manager.
• Must be flexible regarding working hours.
• Must be able to operate in a fast-paced environment and handle multiple projects simultaneously.
• Ensures that staff is contributing at maximum potential through rigorous hiring practices and an emphasis on training and development initiatives, including coaching and counseling direct reports in their performance and professional development, with final authority for approving pay increases, hiring decisions and disciplinary actions.
• Emphasizes ethical leadership and decision-making to protect Peli’s brand and reputation.
• Establishes challenging, productive and achievable goals for direct reports; measure results by establishing checkpoints to track progress.
• Must be able to travel, nationally and internationally, as necessary.

Job Types: Full-time, Permanent

Salary: £88,000.00-£100,000.00 per year

Benefits:

• Company car
• Company pension
• Free parking
• Life insurance

Schedule:

• Monday to Friday

Supplemental pay types:

• Bonus scheme
• Yearly bonus

Ability to commute/relocate:

• Leighton Buzzard: reliably commute or plan to relocate before starting work (required)

Experience:

• Quality assurance: 7 years (preferred)

Work Location: One location

Reference ID: 30349