Job Purpose: To provide a professional and technical leadership to the Pinewood Healthcare Site (Ballymacarbry & Ballymount) and work in conjunction with sister Sites in the Wockhardt Company (India & UK). To establish and maintain regulatory compliant quality systems to ensure that all products are manufactured and distributed in compliance with Group, Company, Contract Client, Regulatory and Safety Standards.Reports to: Ajay Sahni, Managing Director, Pinewood Healthcare, and Global QualityKey Responsibilities:Provide a full technical leadership to the Pinewood Healthcare Ireland, building a technical team who are capable and have a solid understanding of Quality Assurance, Control, Validation, Stability and Microbiology functions.As person named (QP) on the company's manufacturing authorisation, the job holder is personally and professionally accountable for the quality of all products released for sale.Identify and implement process changes to improve product quality and/or reduce processing costs.Assess and resolve any technical issues to ensure appropriate timely solutions are delivered in line with industry standards ensuring effective corrective and preventative actions are instigated.Bring in efficiency in QA/QC operations in Pinewood Healthcare utilising tools such as Lean systems.Delivery of Pinewood Healthcare short- and long-term Quality operations targets.Definition and delivery of Quality strategy in Pinewood Healthcare.Effective direction, management and development of the Quality team in support of the business as a whole.Senior level contribution to general direction and management of the business as a whole.Lead role with regulatory bodies during company audits.To foster excellent communication between all business functions, both internally and externally.Work together with other Wockhardt Quality functions on harmonisation of standards across the Wockhardt Organisation.Skills and Experience:Registered Qualified Person, with considerable experience in QC/QA ManagementEducated Degree level - Chemistry, Pharmacy or Biological ScienceExtensive experience of HPRA, MHRA & EU approved manufacturing site experience.Detailed understanding of the Irish Medicines Act, European Quality Directives, FDA regulations and international cGMP standards to fulfil obligationsSubstantial operations experience, along with a proven track record of successes and achievements.Experience of the Pharmaceutical sector, particularly within Oral liquid, semi-solids, oral dry powders for reconstitution.Proven people-management and leadership expertise.Influences ChangeNumeracy / analytical skills with the ability to work with and set forecasts, budgets, cost control etc.Personal Attributes:The ideal candidate will be a hands-on and strong dynamic leader, who shows enthusiasm and acts professionally at all time.Other key personal attributes will be; high self-motivational levels, and results driven, with and analytical problem-solving ability.Exceptional operational skills and commercial awareness with a strategic vision.Outstanding communication and leadership skills, with the ability to establish credible relationships with customers and suppliers at Director Level. Interacting, persuading, negotiating and influencing key stakeholders both internally and externally.JOB ACCOUNTABILITIESLeadership: Leads the technical team to deliver a service which meets the needs of both internal and external stakeholders. Inspires co-workers to attain goals and pursue excellence. Identifies opportunities for improvement and makes constructive suggestions for change. Manages the process of innovative change effectively. Remains on the forefront of emerging industry practices.Teamwork: Works with colleagues in technical and other departments to achieve the overall company goals. Facilitates effective team interaction. Acknowledges and appreciates each team member's contributions. Effectively utilizes each team member to his/her fullest potential.Solution Development and Delivery: Provides technical direction for the development, design, and systems integration from definition phase through implementation. Applies significant knowledge of industry trends and developments to improve service delivery.Technical Expertise: Is a Qualified Person and maintains and updates knowledge and expertise to ensure the technical function maintains best practice.Communication: Facilitates team meetings effectively. Communicates proactively with other functions. Delivers engaging, informative, well-organised presentations. Resolves and/or escalates issues in a timely fashion. Understands how to communicate difficult/sensitive information tactfully.Continuous Improvement: Strives to continuously improve systems and practices in response to internal and external customer needs.