Sr. Manager, Compliance

Description

Quality, Service, Collaboration, Courage. Do you exhibit these values and wish to be around others that do too? Are you interested in making a difference in your community and the world? Are you looking for a place where you can grow and learn in a diverse, community-minded culture? If these statements resonate with you, Grand River Aseptic Manufacturing (GRAM) welcomes you to apply to join our community of dedicated individuals improving lives every day.

Overview of this Position:

The Sr. Manager of Quality Systems and Compliance provides direction and leadership to GRAMs Quality Management and Compliance Systems with responsibility for ensuring compliance with site's quality systems and applicable regulatory standards. This position works closely with all levels of the Manufacturing Operations, Technical Services, Validation, QC, Business and Finance teams. This is an on-site role.

Non-Negotiable Requirements:

• Bachelor's degree in Life Sciences or a related field and/or a minimum of 10 years related work experience.
• A minimum of 7 years prior management/leadership experience.
• Direct experience interacting with regulatory authorities is required (FDA, EMEA, Heath Canada and Rest of World).
• In-depth knowledge of Quality principles and procedures in a pharma, biopharma, and/or biotech manufacturing environment.
• Experience and expertise in aseptic manufacturing of regulated products with a thorough understanding of cGMP, FDA guidelines and multinational regulatory standards is a must.
• Must have proficient computer skills in Microsoft Word, Excel, PowerPoint and Outlook.

Preferred Requirements:

• Prior experience working in a fast-paced, emerging growth CMO.
• ASQ Certified Auditor

Responsibilities Include (but are not limited to):

• Provide leadership direction for GRAMs Quality Management Systemto Quality Managers/Supervisors and Specialists. Responsibilities include hiring, managing, motivating, resource allocation, coaching and mentoring.
• Work in a collaborative manner with a diverse customer base ensuring commitments and goals are met.
• Ensure Quality support and oversight of the following GRAM Quality Management Systems: Internal Audit Program; External Audits (Agency and Client); Supplier Quality Audits; Customer Complaints, Adverse Events and Recalls; Quality Management Review; Annual Product Quality Reporting
• Oversee regulatory/compliance work such as the DEA Controlled Substance program, regulatory surveillance, and state licensing.
• Develop and maintain quality metrics and site KPIs that support GRAM's QMS.
• Identify trends and escalate potential compliance risks to leadership.
• Host audits, and response findings including audits conducted by representatives of current and/or potential clients, regulatory agencies or other due diligence audit requests.
• Review site metrics, identify trends and escalate potential compliance risks to Director of Quality and VP Quality & Regulatory.

Full job description available during formal interview process.

What Sets GRAM Apart from Other Employers:

MEDICAL BENEFITS starting day 1: Blue Cross Blue Shield medical and dental, vision, life insurance, and disability benefits are available to you and your family on your first day of work, with the company paying for 75% of the cost! Once eligible for the 401(k) program, all your contributions are immediately 100% vested, and you are immediately vested in GRAM contributions as well.

Paid VOLUNTEERISM starting day 1: GRAM encourages giving back to our community by offering 16 hours of paid volunteer time per calendar year!

PTO: Full-time employees accrue up to 13 days of time off per calendar year. You choose how to use this time for your vacation, sick, or mental health needs!

WELLNESS TIME OFF: Employees earn 1 hour of time off for every 30 hours worked to use how you choose.

PAID HOLIDAYS: We offer 10 paid holidays per calendar year with immediate eligibility!

PAY: Depends on Experience and is discussed during the interview process.