Senior Director, Quality - 21265

Job Description

Job Description

Senior Director, Quality - Simply Biotech

OVERVIEW

Are you looking for a new career opportunity with an exciting biotech company?! Then we have got the right team for you! In this role, you are responsible for the duties listed below.

Immediate opening for a Senior Director, Quality in Lenoir, NC who possesses:

• Degree in Pharmacy, Chemical/Process Engineering, or a related Life Science, such as Biology, Microbiology, or Chemistry
• 15+ years of progressive quality management experience
• Proven expertise in Quality, GMP, QC, batch release, and compliance within the pharmaceutical industry
• Strong understanding of continuous improvement focused on LEAN manufacturing, Six Sigma, QbD, and process-oriented approaches

FULL DESCRIPTION: We are seeking a Senior Director, Quality to provide managerial leadership for all quality-related matters across U.S. operations. This permanent, onsite role is responsible for ensuring compliance with cGMP, quality systems, regulatory requirements, product release, QA, QC, quality compliance, audits, inspections, investigations, and continuous improvement initiatives. The ideal candidate will have deep pharmaceutical quality leadership experience, strong GMP and QC expertise, hands-on experience leading quality operations, and the ability to mentor and develop quality teams while driving compliance, operational excellence, and patient-focused quality standards.

The selected candidate will be responsible for:

• Providing managerial leadership for all quality-related matters across U.S. operations
• Ensuring key operational business activities comply with current Good Manufacturing Practices
• Ensuring compliance with applicable U.S. Code of Federal Regulations, global pharmacopeia requirements, state board of pharmacy requirements, and internal quality policies
• Supporting company strategy through sound quality decision-making and patient protection
• Ensuring the Americas region is capable of supplying high-quality products in a timely manner
• Operating within established standards of Quality, GMP, Health, Safety, and Environmental Protection
• Working closely with the Americas Leadership Team to align on business priorities
• Ensuring handling, manufacturing, and distribution of allergy products comply with corporate quality manuals, quality agreements, policies, and regulatory requirements
• Providing general management oversight for U.S. Quality operations
• Ensuring local quality systems and standard operating procedures are in place
• Maintaining cGMP compliance through training and audit
• Ensuring product quality through qualification and validation based on quality risk analysis
• Driving productivity improvement, best practices, and harmonization with technical operations
• Providing leadership, direction, and support to the quality organization
• Ensuring quality team members are qualified, competent, motivated, and working safely
• Maintaining coordinated contact with regulatory authorities, partners, suppliers, third parties, licensees, distributors, Global Quality Operations, and country management
• Auditing, supervising, and coordinating third-party activities
• Ensuring pharmaceutical manufacturing and distribution activities comply with company standards
• Managing complaints, recalls, counterfeits, and product tampering matters
• Providing direction, formulating strategies, and making decisions that support efficient organizational operations
• Supporting timely implementation of safety, security, industrial hygiene, and ecology regulations within the QA department
• Providing direct oversight of Quality Assurance and Quality Control departments
• Overseeing all product release activities
• Overseeing the site supplier qualification and auditing program
• Leading and reporting progress on quality improvement projects within quality, laboratory, and manufacturing areas
• Coordinating and participating in FDA inspections and customer audits
• Identifying and implementing modern manufacturing and quality systems to meet business needs
• Leading quality investigations as needed
• Overseeing subordinate functions including Quality Control, QA Product Release, Quality Compliance, Ancillary Operations QA, Complaints Management, and related quality functions
• Managing the annual Quality organization budget as appropriate
• Developing direct reports and supporting talent review, development actions, attraction, and retention of key talent
• Supporting operational excellence, quality culture, and continuous improvement initiatives
• Performing other duties as assigned

The selected candidate will also possess:

• Degree in Pharmacy, Chemical/Process Engineering, Biology, Microbiology, Chemistry, or a related Life Science required
• Advanced degree, such as Ph.D. or Pharm.D., preferred
• 15+ years of progressive quality management experience required
• Pharmaceutical sector experience required
• Pharmaceutical GMP experience required
• QA functional leadership experience strongly preferred
• Proven knowledge of cGMP requirements required
• Experience with aseptic preparations preferred
• Experience with physician-use allergenic products preferred
• Proven QA expertise across Quality, GMP, QC, batch release, and quality compliance required
• Strong understanding of current Good Manufacturing Practice guidelines
• Strong understanding of CMC team responsibilities, clinical production guidelines, and product registration requirements preferred
• Experience managing end-to-end quality systems and closing quality gaps
• Experience leading QA, QC, product release, compliance, complaints, investigations, and supplier qualification functions
• Experience with CAPAs, deviations, OOS, EMPQ, batch release, and quality systems preferred
• Experience coordinating or participating in FDA inspections and customer audits required
• Experience managing external relationships with government bodies and regulatory authorities
• Experience implementing or improving modern manufacturing and quality systems preferred
• MasterControl experience preferred
• POMS implementation experience preferred
• Strong continuous improvement focus with understanding of LEAN manufacturing, Six Sigma, QbD, and process-oriented approaches preferred
• Strong leadership and management capability
• Ability to engage, motivate, mentor, and develop empowered teams
• Ability to manage quality operations with a hands-on leadership approach
• Ability to lead direct reports across multiple quality functions
• Ability to operate effectively in a fast-paced, evolving environment
• Ability to make well-founded decisions based on quality compliance and business factors
• Strong analytical, strategic, and problem-solving skills
• High integrity, executive presence, and strong communication skills
• Ability to work cross-functionally with manufacturing, laboratory, regulatory, quality, and leadership teams
• Ability to manage multiple priorities and achieve goals with limited resources
• Ability to work 100% onsite in Lenoir, NC
• Ability to support a permanent opportunity
• No sponsorship available

Physical Requirements:

• Ability to sit and work at a computer for extended periods while reviewing quality records, batch records, regulatory materials, audit documentation, quality systems, reports, procedures, and technical documentation
• Ability to communicate by phone, email, video meeting, and in person throughout the workday
• Ability to review detailed quality files, compliance records, investigation materials, product release documentation, inspection materials, and computer screens for extended periods
• Ability to occasionally stand, walk, bend, reach, and move throughout office, manufacturing, laboratory, quality, warehouse, and inspection areas as needed
• Ability to participate in audits, inspections, quality walk-throughs, and cross-functional meetings as needed
• Ability to occasionally lift, carry, or move standard office files, quality documentation, binders, or business materials as needed
• Ability to work in pharmaceutical manufacturing, laboratory, quality, or controlled environments while following applicable safety, GMP, and site procedures
• Ability to wear required personal protective equipment as needed when entering manufacturing, laboratory, warehouse, or quality areas
• Ability to travel as required from time to time for business, quality, regulatory, audit, or inspection-related needs

Salary Range: $210,000 to $250,000/year plus 20% bonus
More information can be found at

Simply Biotech was founded in 2008 and has been repeatedly recognized as one of San Diego County's fastest growing businesses. In 2025, we were named Business Journal's 'Best Places to Work'. Even as our competitors are scaling back and laying off staff, Simply Biotech is expanding to new markets and hiring additional staff in existing offices.

Company Description

Simply Biotech was founded in 2008 and has been repeatedly recognized as one of San Diego County's fastest growing businesses. In 2025, we were named Business Journal's 'Best Places to Work'. Even as our competitors are scaling back and laying off staff, Simply Biotech is expanding to new markets and hiring additional staff in existing offices.