Who we are:

Solesis is an innovative provider of biomaterials solutions and services primarily focused on the MedTech and Biopharma industries.

About the role:

The Senior Manager of Quality and Regulatory is responsible for leading the Quality Operations across the North Carolina sites, including Document Control, Quality Assurance, Quality Engineering, and all QMS requirements including but not limited to internal/external audits, document control, product release, complaints, CAPA, NCRs, deviations, inspections, Management Review, training, regulatory reporting obligations PMS, labelling, sterilization and environmental monitoring programs. The position meets the Company’s quality objectives directly or through subordinate supervisors or individual contributors. This position will be responsible for our facilities in Winston-Salem, NC and Apex, NC.

What you will do:

• Ensures the promotion and awareness of regulatory and customer requirements across multiple sites.
• Maintains product quality by enforcing quality policies, procedures, and applicable statutory and regulatory requirements.
• Act as the Quality liaison between the organization and customers.
• May serve in the capacity of Deputy Management Representative or designee.
• Responsible for maintaining ISO 13485:2016 and ISO 9001:2015 certification and compliance with 21 CFR Parts 820, 210, and 211.
• Interprets and communicates international regulatory product requirements, submits and maintains product registrations as applicable.
• Lead the Quality and Regulatory Planning in conjunction with the company’s strategic objectives.
• Compiles and assists with data analysis and overall trending, including Key Performance Metrics for review on monthly, annual and during Management Review meetings.
• Identify and communicate changes to standards and regulatory requirements.
• Responsible for ensuring the conformity of products is appropriately checked per quality system requirements before the release and, when necessary, certifies finished goods.
• Provides oversight to sterilization processes.
• Reviews and approves validation documentation, product specifications, and standard operating procedures (SOPs) and any revisions to these documents, ensuring they are conducted in accordance with the requirements of the FDA and ISO regulations.
• Review and authorize deviations and, when necessary, facilitate appropriate review boards for deviations and specification changes.
• Collaborates cross-functionally with other members of management to develop new products and engineering designs.
• Review and support customer advisories, post-market surveillance, and is responsible for the disposition of authorization returns as applicable.
• Support training on the Quality Management System as needed.
• Assist manufacturing teams with continuous improvement initiatives.
• Monitor nonconforming product disposition and control, advise senior management, as necessary.
• Support the evaluation of raw material out of specifications and determining the disposition of any rejects, quarantines, etc.
• Ensures label claims and content of promotional materials meet statutory and regulatory requirements.
• Partner with Human Resources to maintain adequate staffing levels for the Quality Team.
• Provides coaching, feedback, and guidance to team members on a continual basis and takes an active role in developing, monitoring, and updating a career plan for advancement.
• Completes performance appraisals and reviews with employees; recommends salary increases to management and HR.
• Provides input to the department budgeting process and monitors and controls expenses throughout the year to meet budget requirements.

Who you are:

• Bachelor’s degree (B.S.) in a life sciences discipline or related degree.
• Five (5) to eight (8) years of related experience in the pharmaceutical or medical device industry.
• Two (2) to Three (3) years of leading a team or managing direct reports.
• SME in ISO 13485/9001practices or possesses the ability to understand and enforce regulatory requirements.
• Knowledgeable in 21CFR820, ISO9001 and cGMP’s.
• Strong organizational and time management ability.
• Ability to manage a technical project, understanding the client’s needs, how the needs relate to the scope of the project, and how changes will affect other systems.
• Excellent interpersonal skills with proven ability to get along well with others and work in a team environment.
• Excellent verbal and written communication skills
• Excellent customer service focus and professionalism
• Ability to independently prioritize and execute projects and responsibilities
• Energetic, enthusiastic, and motivational disposition
• Self-starter with the ability to work in a high-paced environment with limited direction.

Perks / Benefits:

• Generous Paid Time Off
• Annual Bonuses
• 401k with excellent company match
• Health Insurance with multiple plans to choose form
• Paid Short Term and Long Term Disability