Become our QA Manager
To support its QA department, UniD manufacturing is hiring a QA Manager. He or she is a member of the Quality Assurance Leadership Team reporting directly to the Quality Director. He or she provides leadership and direction for ensuring that the development and manufacturing activities are conducted in accordance with relevant standards and regulations to support UniD’s projects. He or she must fully support and drive the CDMO activities and communicate effectively with the different stakeholders such as other department’s head.
As a QA Manager in the Quality department at UniD Manufacturing the candidate will
- Select, empower, coach, retain a team of qualified individuals through effective employee development.
- Facilitate the daily QA team performance to ensure goals and objectives are met.
- Promote Quality Culture by providing guidance, support, direction and leadership through positive interactions with all personnel.
- Ensure strong alignment and coordination with other departments.
- Provides oversight and guidance on quality compliance to all departments and project teams.
- Oversee the Quality Management Systems.
- Lead or support the development and/or revision of quality processes, procedures and risk assessment tools, ensuring proactive compliance and adherence to regulations and standards.
- Ensure that documentation supporting activities complies with customer and regulatory requirements.
- Oversee investigations activities associated with complaints, deviations, laboratory event etc. and collaborate cross-functionally to ensure risk-based solutions are implemented in a timely manner.
- Make decision regarding quality issues and ensure appropriate communication and/or escalation.
- Utilize knowledge to improve operational efficiency. Work closely with others to identify opportunities for improvement and drive change. Lead teams in continuous improvement project activities.
- Support internal audits.
- Provides metrics and analytics for Management Review.
- Provide proactive quality assurance and risk assessment using various risk management tools (e.g. FMEA, HACCP, PHA); and implement risk mitigation measures.
- Participate in the evaluation and selection of suppliers and service providers and ensure appropriate agreements are in place.
- Practice safe work habits and adhere to UniD’s safety procedures and guidelines.
- Relevant Academic degree – preferably a Master of Sciences in Pharmacy or the like.
- Minimum 7 years in quality roles of increasing responsibility, impact, and scope within a pharmaceutical and/or medical device environment.
- Minimum 3 years demonstrated experience in a leadership role.
- Detailed knowledge of worldwide healthcare product quality compliance regulations (EMA and FDA as a minimum), guidance (including ICH) and standards (including ISO 13485 and ISO 14971).
- Thorough knowledge of the requirements associated with the development of drug product or medical devices, or a combination of both.
- Effective leadership skills, including the ability to set goals and provide constructive feedback respectfully to build positive relationships and improve business results.
- Strong organizational, planning, and follow-up skills and ability to hold others accountable.
- Ability to multi-task and shift priorities quickly while working under tight deadlines.
- Demonstrated ability to resolve quality and quality system-related issues in a timely and effective manner.
- Ability to work effectively alone or within a team, in a fast-paced changing environment.
- Excellent verbal and written communications with ability to effectively communicate at multiple levels in the organization, to foster support and to positively influence all stakeholders.
- Proactive, risk-based approach with strong critical thinking skills.
- Mental agility to handle a large quantity and broad scope of information and activities while keeping making sound decisions.
- Advanced computer skills in MSOffice applications and experience using enterprise systems (eg ERP/eDMS/eQMS/LIMS, etc).
- Integrity, team spirit and caring
- Proficient in English at a professional level, both written and spoken
UniD Manufacturing offers:
• A permanent position in an innovative and dynamic and fast-growing company.
• A fulltime job
Please send your CV and cover letter in English to : job[@]eyedpharma.com