Altea Therapeutics is a pharmaceutical company that uses breakthrough technology to deliver therapeutic proteins, peptides, vaccines and conventional drugs through the skin in a noninvasive and controlled manner. The people of Altea Therapeutics are developing advanced therapies to treat severe and debilitating diseases. 

The Sr. Quality Assurance Manager will work with all Altea Therapeutics’ departments in establishing and maintaining cGMP compliance for all products.  The incumbent will employ a variety of measures to place quality at the core of our organization. These include management systems such as GMP, Total Quality Management and Continuous Improvement processes. This position reports to the VP, Regulatory Affairs and Quality Services.

Key areas of Responsibility:

·         Develop, establish and maintain quality assurance programs, systems, policies and controls;

·         Provide expertise and guidance in interpreting governmental regulations, agency guidelines and internal policies;

·         Serve as liaison between the company and various governmental agencies;

·         Work directly with business units to ensure that inspections, statistical process control  analyses and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications;

·         Establish and ensure business partners achieve the appropriate level of compliance and develop actions to ensure on-going performance is achieved and maintained through metrics;

·         Manage  the part number system, the equipment system, including release of equipment and equipment qualifications, the raw materials system (GMP receiving), internal auditing, vendor/contractor auditing, including product specifications and customer requirements, clinical inventories;

·         Maintain and follow-up on documentation systems (deviations, change controls, investigations);

·         Review of quality documentation such as batch records and stability data;

·         Ensure compliance with national and international standards and legislation;

·         Collate and analyze performance data against defined parameters;

·         Ensure tests and procedures are properly understood, carried out and evaluated and that product modifications are investigated if necessary;

·         Write technical and management system reports;

·         Function as liaison with customers' auditors and ensure the execution of corrective action and compliance with customers' specifications.

Requirements

·         Bachelor’s degree in an applicable biomedical or life science discipline with at least 7 years Quality Assurance experience in the pharmaceutical/device industry

·         Must be able to interpret, execute and recommend modifications to company wide policies to achieve corporate goals and objectives;

·         Excellent oral and written communication skills;

·         Demonstrated ability to lead a team through practical application of quality system principles;

·         Ability to create a learning culture that enables individuals to reach their maximum potential and build the capability of the organization;

·         Communicates a clear vision and expectations that creates energy, enthusiasm and commitment from others

We seek highly creative individuals with excellent written and oral communications skills, able to work in a multi-disciplinary team to achieve project goals under challenging timelines.