Quality Assurance Director
Description
Do you believe quality is part of a company’s culture and are passionate about cultivating the right environment for employees and the business to thrive? Reed-Lane, located in Wayne, NJ, is looking for the right Director of Quality Assurance who’s not just tactical and process-focused but an inspiring leader coaching and motivating everyone to approach their work through the lens of quality in the pharmaceutical packaging industry.
What you’ll do
Inspiring a culture of quality by deploying your technical, functional, and leadership skills to keep customers happy and the company in compliance with the regulations of the FDA, DEA, etc. As the Director of Quality Assurance, you’ll:
- Lead the organization’s operational compliance to cGMP as well internal SOP’s and customer-required protocols in accordance with CFR Title 21, Part 11, 210 & 211 as well as ICH and EU Guidelines.
- Develop and manage the systems and procedures governing the handling of products and components
- Lead and develop the quality assurance team managing 6 direct reports and the quality team
- Oversee internal along with external audits with Customer Quality Units and Regulatory Agencies
- Review and approve of facility monitoring, testing, calibration and qualification required by company SOP’s
- Assure all deviations, non-conformances, and customer complaints are appropriately investigated and that necessary corrective and preventive actions are documented, implemented, and deemed effective
- Negotiate and implement Quality Agreements
- ERP System compliance support
- Oversee all required State and Federal Registrations and manage List 1 Chemical Quota Applications and Quota Inventories
- Manages DEA requirements, and prepare/submit quarterly ARCOS reporting
What you need to thrive in this role
- BA in an affiliated Science
- Minimum of 5 years Quality Assurance Management experience
- Proficient knowledge of GMP, CFR Title 21 Parts 11, 210 211 as well as EU and ICH Guidelines
- Proficient knowledge of Pharmaceutical packaging as well as component and product testing
- Spanish speaking is a plus!
About us
Headquartered in Wayne, NJ, Reed-Lane is a pharmaceutical contract packager who has been providing innovative packaging solutions to pharmaceutical companies since 1959. We aren’t making the pharmaceuticals but rather supporting our pharmaceutical partners with their packaging needs. Because we are a privately held company, Reed-Lane serves the complex, ever-changing needs of its customers with great speed and agility. Our team-focused culture begins at the top and is evident throughout the company. The teamwork and open communication allow us to exceed both regulatory requirements and our customers’ high expectations of quality, timeliness, and professionalism. Reed-Lane’s team focus has resulted in many of our employees staying with Reed-Lane much longer than the industry average. They possess an in-depth familiarity with every aspect of the contract packaging process. If you’d like to learn more, visit our website: https://reedlane.com/
What we offer you
We care about our employee's well-being:
- Medical and dental insurance
- Company-paid life insurance
- Company-paid long-term disability insurance
- Paid time off
- Holidays
- 401k with company match
- Discretionary company-wide bonuses as profitability allows
- Salary range of $150-195k depending on experience
I’m interested, how do I get started?
Apply to https://app.jobvite.com/j?cj=oXi1ufwu&s=myHRpartner:
Is this the job for you? If not, feel free to share this link with someone who might be interested.
Our hiring management partner is myHR Partner. myHR Partner is not a staffing service or recruiter. All resumes/applications will be reviewed for this position and only for our organization.
Thank you for considering us as a potential employer!
At Reed-Lane, we continually celebrate the diverse community different individuals cultivate. As an equal-opportunity employer, we stay true to that by ensuring that our place can be anyone’s place.