Senior Specialist - Quality Assurance Excellence - Pharma (5-10 yrs)
- Develop and implement cost improvement projects through operational efficiencies.
- Develop policies and define the standards for group manufacturing excellence.
- Work closely in conjunction with other OE Managers in US, EU & IN sites and the Director of OE (US, EU & IN) to implement improvement initiatives such as simplification and harmonization of SOPs/BMRs across sites, enhance training programs across sites and work on other need based enhancement/remediation projects across sites
- Support development of training material for Curia sites
- Conduct diagnostics to identify areas for improvement.
- Conduct value stream mapping exercises to define processes; work with the site to implement or streamline/improve use of LEAN tools, 5S, Six SIGMA, etc.
- Propose and support the projects and programs within the businesses for the identification of improvement levers, setting smart objectives and carrying-out Quality Assurance Excellence programs.
- Support the execution of improvement projects by promoting use of proven tools and approaches to achieve Quality Assurance excellence.
- Ensure sufficient focus on sustainability of improvements through providing training and skill building of leaders.
- Lead and mentor leadership team members, facilitating a culture that motivates employees.
- Recommend and implement methods to increase the quality of products and/or services.
- Participate in self-development activities and training of others.
- Exhibit safety awareness and safe work practices. Protect employees and visitors by maintaining a safe and clean working environment.
- Perform other related duties as may be reasonably assigned in the course of business or as requested.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Education: Bachelor's degree or equivalent preferred; Education with a scientific background is highly desired.
Relevant Work Experience: At least 5+ years' experience in Quality Assurance in a regulated pharmaceutical plant, operational excellence / continuous improvement, or pharmaceutical consulting role required.
Knowledge, Skills & Abilities:
- Degree in Science or Engineering, pharmacy
- Proven experience with Lean Six Sigma experience to drive business results
- Knowledge of expectations of regulatory authorities such as FDA, EMA, WHO
- Exposure in Compliance, Quality Systems, Quality Assurance
- Good Technical Writing Skills
- 5+ years' industrial experience, site leadership position a plus
- Strong technical skills
- Impact and influence skills and strong experience in change management
- Project Management skills
- Ability to lead and respond to changing environment