Quality Systems Manager

Scope:

The Manager, Quality Systems is responsible for the oversight of all assurance related activities related to the manufacture, packaging, testing and release of drug/dietary supplement products. The Manager, Quality Systems is responsible for departmental SOPs, Policies and Procedures related to the assurance and compliance of Good Manufacturing Practices (GMP's). The Manager, Quality Systems oversees Quality Assurance associates ensuring a clean, safe workplace and quality production of drug product.

The Manager, Quality Systems is a member of the Quality team, responsible for the safe, efficient, manufacturing and over site of drug/dietary supplement products.

Essential Duties and Responsibilities:

• Provide specific Quality Assurance input, guidance, decisions and actions related to Quality Systems and Standard Operating Procedures
• Provide Quality Assurance approval of SOPs, protocols and other documents as appropriate
• Coordinate compliance activities related to all batch manufacturing, packaging, testing and release of drug/dietary supplement products
• Establish, maintain and continually improve the overall Quality System.
• Develop and implement quality-related training programs for management and QA associates.
• Track quality assurance metrics.
• Provide leadership on regulatory, customer and 3rd party audits.
• Keep all Future Pak documentation current with FDA regulations and other product regulatory requirements.
• Act as Quality Assurance customer contact for QA related issues/initiatives; coordinate participation of other members of the account team as appropriate.
• Act as primary advisor to the operations management team on QA issues/initiatives (e.g. problem solving, identification and escalation of significant QA issues).
• Other duties as assigned by the Company or your Supervisor
• Experience in Solid Dosage Pharmaceutical products and dietary supplements is a Plus
• Experience in managing inspections conducted by regulatory bodies, is desirable.

Behavioral Expectations:

• Strong work ethic and ability to accomplish tasks without supervision.
• Adhere to and follow all Company Policy and Procedures
• Ability to exhibit leadership, both by word and example.
• Excellent interpersonal skills with the ability to cooperate with others in a high-performance setting.
• Basic computer skills (proficient in Microsoft Office applications).
• Strong mathematical and organizational skills.
• Excellent English communication skills, both written and verbal.
• Must possess honesty and integrity, commitment to the highest legal and ethical standards
• Ability to treat every person with courtesy and respect
• Demonstrate ownership and accountability to production schedule without compromising product quality
• Knowledge of fundamental cGMP and regulatory principles

Work Experience and Education Requirements:

• Minimum of 5 years' experience in the pharmaceutical industry.
• Four-year degree

Job Type: Full-time

Pay: $80,000.00 - $90,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• 10 hour shift
• 8 hour shift

Ability to commute/relocate:

• Wixom, MI 48393: Reliably commute or planning to relocate before starting work (Required)

Education:

• Bachelor's (Preferred)

Experience:

• Pharmaceutical Industry: 5 years (Required)

Work Location:

• One location

Work Remotely:

• No

Work Location: One location