Compliance Manager

Just is seeking a highly motivated individual who desires a significant opportunity to improve worldwide access to biotherapeutics. We are looking for someone to join a fast paced, collaborative, and multidisciplinary team as a senior contributor supporting compliance and auditing activities. You will be responsible for ensuring maintenance with industry regulations/expectations as applicable to governing quality systems. You will be responsible for coordination and execution of internal and external audits per applicable global procedures. You will lead cross site efforts/projects in support of compliance which will help in fostering the achievement of the company's global mission.

As a Manager, you will apply sound technical and quality knowledge to interpret and apply regulations/requirements across a broad range of cGMP activities, and provide sound guidance/direction to GMP functions. You make complex and routine decisions with minimal guidance from management. You have a solid understanding of quality systems as they relate to the manufacturing, testing of API/drug substance starting materials. You're continually expanding your knowledge of quality requirements. You will navigate global systems and identify and manage different levels of risk in support of good quality judgment against global systems and regulations, including advising the business on moderately complex quality issues.

Responsibilities:

• Responsible for collaborating with the Site Compliance Lead to support Inspection Readiness activities for client audits and inspections ensuring a state of readiness.
• Ensures the site organization has an ‘Inspection Ready’ program with personnel preparation for hosting/supporting inspections and inspection follow up; Interact with partner and Health Authority auditors as the SME and support the audit process.
• Responsible to develop, adhere to and execute against the internal and external audit schedule to meet procedural requirements.
• Coordinate end to end audit and inspection readiness activities.
• Leads the internal and external auditing team and executes internal and external audits to ensure compliance with current regulatory expectations, including sound audit preparation, and execution.
• Monitor and report status of remediation actions resulting from audit and inspection findings and drive efforts through to completion
• Contributes to the maintenance of the audit program in compliance with applicable Just Evotec Biologics Quality Standards, as well as continuous improvement of the program.
• Ensures ongoing presence within GMP manufacturing and testing areas to assist Just Evotec Biologics ability to maintain exemplary compliance.
• Establishes her/himself and the team as SMEs for cGMP related compliance and acts as a resource to GMP functions as needed.
• Collaborates across the network and industry to identify and replicate best practices for auditing and to maintain currency with latest regulatory expectations.
• Implement and maintain the internal audit and client audit program including planning of audit events and performance of the internal audit in accordance to the annual schedule
• Monitor, publish and report audit and inspection metrics in accordance to Quality Management Review requirements.
• Review and analyze Compliance data to look for trends, opportunities, and advise leadership through metrics.
• Executes moderately complex tasks with minimal coaching.
• Leads and/or participates on special projects, limited duration teams, and local or global initiatives such as continuous improvement teams.
• Manage IT tools which supports the Inspection Readiness activities for audits and health authority inspections.
• Demonstrate a flexibility and agility to fit any future business needs.

Qualifications

Must-Have

• Bachelor's Degree with 10+ years of relevant experience within the pharmaceutical industry OR MS with 8+ years of relevant experience within the pharmaceutical industry.
• Direct Experience hosting and/or leading Regulatory Inspections, Client Audits and continuous improvement projects
• Extensive knowledge of global GMP and regulatory requirements as related to the pharmaceutical drug manufacturing process is required (Data Integrity, Part 11, etc.).
• Strong evidence of collaborative nature, with strong interpersonal, organizational, and communications skills are a must.
• Self-motivated, engaged and able to perform moderately complex tasks independently.
• Experience with auditing of pharmaceutical manufacturing, testing, and storage operations.
• Leadership experience required (direct leadership, project leadership, and/or indirect leadership).

Physical/Mental Requirements

• Ability to gown and enter the manufacturing suite as needed.
• Mental agility to handle a broad scope of different types of quality assurance work (i.e., reviewing documentation, conducting audits and hosting inspections, communicating one on one or with larger groups). Ability to independently problem-solve and make recommendations for solutions.
• As this role will represent Just Evotec Biologics to third parties or regulatory inspectors it is essential that the candidate has the ability to remain calm under pressure and is able to adjust and modify their style dependent upon the specific audit situation.
• This role will be a combination of remote work and onsite work.

The base pay range for this position at commencement of employment is expected to be $115,000 to $140,000; Base salary offered may vary depending on individual’s skills, experience and competitive market value. Additional total rewards include discretionary annual bonus, comprehensive benefits to include Medical, Dental and Vision, short-term and long-term disability, company paid basic life insurance, 401k company match, flexible work, generous paid time off and paid holiday, wellness and transportation benefits.

FR : Dans le cadre de sa politique Diversité, Evotec étudie, à compétences égales, toutes les candidatures dont celles des personnes en situation de handicap.

ENG : In the frame of our Diversity policy, Evotec considers, with equal competences, all applications including people with disabilities.