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SalaryAker BioMarine is a leading biotechnology company developing krill-derived products for consumer health and wellness and animal nutrition. The company has a strong position in its industry.
In Aker BioMarine we believe in a world where everyone has access to quality nutrition and good health without compromising the planet.
We are looking for more people like us, who believe they can make a difference in the world.
We are about 550 employees globally, with more than 40 nationalities, spread across all time zones and most continents. Together, we form an international, high performing, diverse and fun work environment.
Working with us means you appreciate diversity, are highly skilled within your field and can cope with unexpected situations. You enjoy a fast pace, tolerate quick decisions and continuously ongoing changes. You are a true team player who “chips in” when the situation requires so.
QA Director will be responsible for developing and implementing a comprehensive QA strategy, managing the QA team, and collaborating with cross-functional teams to ensure the highest level of product quality.
Duties/Responsibilities
- Develop and implement a comprehensive Quality Assurance strategy, including measurable goals and objectives
- Responsible for translating the company’s quality strategy into SOPs, tactical policies, processes, and procedures to ensure 100% compliance with meeting global regulatory standards at all times
- Asses current, and where needed, develop corporate and/or other organizational polices related to compliance and oversee their implementation, including quality standards and SOPs
- Implement governance plan to ensure good communication and decision making at the appropriate levels for quality-related topics
- Develop, implement and monitor Quality operation budget to ensure compliance with approved expense limitations
- Ensure company is regulatory inspection ready at all times (Regulatory Agencies and Client)
- Lead the planning and conduct internal and external audits to ensure compliance with FDA, NSF, NOAA and customer audits and implement the appropriate corrective actions.
- Manage, as the primary point of contact, internal and regulatory agency inspections
- Develop and manage relationships with senior Quality representatives from clients, vendors, and collaborators.
- Collaborate with cross-functional teams, such as development, product management, and customer support, to integrate quality processes throughout the site.
- Communicate effectively with stakeholders at all levels, providing regular updates on quality initiatives and issues
Required Skill/Abilities
- In-depth knowledge of cGMP’s, FDA regulations (21 CFR Parts 210, 211)
- Understanding and knowledge of the GMP regulations of dietary supplements in US
- Experience in quality systems, especially Change Control, Deviations, CAPA, Customer Complaints, SOPs (Standard Operation Procedures), Internal Audit, Supplier Qualification
- Good understanding of GMP Pharma (OTC products)
- Knowledge of Food/Feed GMP requirements issued by FDA
- Knowledge of HACCP analysis and plans
- Understanding of FSMA & FDA requirements
- Effective communication skills, both written and verbal
- Ability to act effectively as a member of a team to resolve problems
- Good organizational and time management skills
- Proficient with handling/performing investigations, including root cause analysis, corrective and preventive actions for audit observations, product complaints, and product nonconformances.
- Must be able to access and navigate each department at the organization’s facilities.
Education and Experience
- Master’s degree in technical or scientific discipline preferably Food Science or Microbiology
- A minimum of 15 years related experience in the food, nutrition, dietary, pharmaceutical and or pharmacy industries.
