QA Compliance Manager

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Aug 25, 2021🔗 👁️ 194 194 Views

🏢 Curaleaf 📍 Portland, OR

💰 DOE 🗓️ Full-time 🏷️ Compliance 📛 OLCC Workers Permit

About our company

Curaleaf Holdings, Inc. (CSE: CURA) (OTCQX: CURLF) ("Curaleaf") is a leading international provider of consumer products in cannabis, with a mission to improve lives by providing clarity around cannabis and confidence around consumption. As a high-growth cannabis company known for quality, expertise, and reliability, the company and its brands, including Curaleaf and Select provide industry-leading service, product selection, and accessibility across the medical and adult-use markets. In the United States, Curaleaf currently operates in 23 states with 108 dispensaries, 22 cultivation sites, and over 30 processing sites, and employs over 5,000 team members. Curaleaf International is the leading vertically integrated cannabis company in Europe with a unique supply and distribution network throughout the European market, bringing together pioneering science and research with cutting-edge cultivation, extraction, and production. Home | Curaleaf | Cannabis with Confidence

Our corporate social responsibility is Rooted In Good Diversity, Equity, Inclusion + Social Equity + Sustainability Social Responsibility | Curaleaf | Cannabis with Confidence We believe in taking corporate and social responsibility very seriously, from our educational outreach to national partnerships, state-wide initiatives and local causes. Giving back to the communities where we operate is important to us, and helps to change old attitudes by showing the positive impact of cannabis in creating jobs, changing lives, and helping local communities.

We educate. We advocate. We give.

Job description

The Compliance QA Manager will be responsible for ensuring compliance with regulations, policies, and procedures, creating process maps, reviewing and supporting standard operating procedures (SOPs), and delivering employee training for facilities located in the state. In addition, the Compliance QA Manager will be responsible for supporting the national standardization of processing and manufacturing procedures, technology, and business practices at a state level in collaboration with the Regional Quality Director and Regional Compliance Director. The Compliance QA Manager will support ongoing operations, working closely with senior leadership to continuously improve operations. This role will develop key relationships with other Curaleaf teams including, but not limited to: Commercialization, IT, Manufacturing, Operations, and Cultivation.

Responsibilities:

• Monitor and maintain all quality and compliance programs and processes within the state.
• Assist in development and implementation of state-specific Standard Operation Procedures (SOPs) and oversight regarding compliance and quality requirements. Continuously monitor SOP implementation and operational adherence to written procedures.
• Perform required audits at all dispensaries and cultivation and processing operations. Identify risks and mitigate potential impact to employee safety, product quality, and cGMP compliance.
• Act as the site coordinator with state regulators and respond to audits and incidents that require regulatory reporting. Identify and oversee internal remediation as necessary, subject to Compliance oversight.
• Communicate issues to employees in a clear, consistent, and effective manner.
• Effectively and professionally communicate with regulators and inspectors.
• Serve as a subject matter expert and resource for staff concerning products and services, policies and procedures, and changes in regulations.
• Review and submit all product specifications to regulatory authorities for review and approval. As needed, communicate with regulators on requested changes to the products.
• Review and approve all proposed product packaging and labeling for compliance with state specific regulations. Make recommendations when needed to Commercialization team.
• Identify all potential, serious, or systemic problems affecting product quality or compliance and report such to the Regional Directors. Participate in updating procedures and validation processes. Review and assist with policy changes and updates applicable to the state.
• Enforce quality assurance standards and provide technical and regulatory support in production and packaging.
• Asisst site leadership with training and qualification procedures for team members.
• Manage quality events and work with operational teams to correct and document Non-Conformance and other Quality Events.
• Enforce and monitor the vendor approval process for incoming products and consumables.
• Enforce and monitor the hold and release program for the state.
• Monitor sustainment of corrective actions from both internal and external audits.
• Assist, encourage, and participate in continuous quality improvement process through reinforcement of product quality, new processing and manufacturing technologies, and assist in creation of site-specific supporting documents to SOPs and policies.
• Partner with Regional Directors to ensure the company is maintaining all standards set forth by State and Federal regulations and guidelines.
• Provide advice to the business to ensure OSHA and local EHS compliance.
• Partner with operations to ensure preventative maintenance and calibrations are performed for site equipment and instrumentation.
• Provide guidance to capex planning and execution regarding manufacturing and cultivation cGMP and regulatory requirements.
• Responsible for new and renewal licensing requirements.
• Responsible for communicating all document changes to Document Control Manager to update the eQMS and ensure document retention in compliance with requirements of 21 CFR part 11.
• Train and develop staff using SOPs, MBRs, and supporting documents in the eQMS.
• Perform periodic reviews of procedures, forms, logs, and master batch records (MBRs).
• Manage functionality of eQMS and assist with deployment of the QMS at state level.
• Become proficient in cannabis laws and regulations for applicable state.
• Promote a culture of quality and change management by empowering team members and colleagues.
• Additional duties and responsibilities will be assigned as necessary.

Qualifications:

• Experience or background in one more of the following industries: food, cannabis, life sciences, or healthcare; undergraduate degree highly desired.
• 3-5+ years of relevant experience
• ISO, GMP, HACCP, OSHA, or similar certification experience
• CAPA and Change Control program experience highly desired
• Strong analytical skills with attention to detail.
• Advanced MS Office and Excel skills required.
• Excellent oral and written communication skills.
• Strong knowledge of QMS; experience with laboratory processes and/or pharmaceutical or food manufacturing preferred.
• Results-driven and task-oriented.
• Flexible and creative, while maintaining a strong work ethic and the ability to meet critical deadlines.
• Prioritize under pressure and ability to identify and solve key roadblocks
• Excellent communication skills and ability to interact professionally at all levels within the organization, with vendors, and outside stakeholders.
• Subject to background check per state cannabis requirements.

Other Details: This is a full-time position with travel to sites within the state required.