Staff Quality Specialist

COMPANY DESCRIPTION:

Syner-G BioPharma Group and Sequoia Biotech Consulting recently merged in September 2024, uniting two industry leaders to create a new force in life sciences consulting. By combining our expertise in product development, regulatory strategy, quality and compliance and commercial manufacturing, we are positioned to deliver fully integrated solutions across the development continuum. 
 
We are helping to enhance human health. This merger strengthens our ability to accelerate groundbreaking therapies and help clients navigate the complex life sciences landscape with greater agility and confidence. Together, we form a leading life sciences consultancy dedicated to empowering organizations to overcome complex challenges and accelerate the speed to market, scale and quality of life-saving innovations.  

We work across a diverse range of clients and projects, supporting many organizations through the most critical phases of the drug discovery, approval, product development, technology transfer and commercial manufacturing process. We also equip our partners with the tools, knowledge and expertise to streamline operations, enhance quality and ensure compliance. 

Syner-G BioPharma Group was recently honored with BioSpace's prestigious "Best Places to Work" 2025 award, for the second consecutive year, along with many other award-winning programs to make a career here truly life-enhancing. These recognitions are a testament to our commitment to fostering a positive and engaging work environment for our employees, with a particular emphasis on culture, career growth and development opportunities, financial rewards, leadership and innovation. 

At Syner-G and Sequoia, we recognize that our team members are our most valuable asset. Join us in shaping the future, where your talents are valued, and your contributions make a meaningful impact. 

For more information, visit www.Sequoiabiotech.com/ or www.Synergbiopharma.com

POSITION OVERVIEW:

Sequoia is seeking a Quality Assurance Staff Specialist to support the Large-Scale Manufacturing (LSM) Modernization project, bringing a new Manufacturing Execution System (MES) to the drug substance manufacturing area. This role will support the operational readiness workstream and activities associated with ensuring the site is ready to receive this change and sustain it within routine production operations. The ideal candidate will have a strong background in quality and understanding of regulations, as well as experience in drug substance manufacturing and documentation processing within a digital document management system.

KEY RESPONSIBILITIES:

(This list is not exhaustive and may be supplemented and changed as necessary.)

• Large Scale Manufacturing (LSM) Modernization Project:

  • Support the LSM Modernization project for bringing a new MES to the drug substance manufacturing area.
  • Encompass several phases covering electronic equipment tracking, electronic batch records, and release by exception functionalities.
  • Assist in daily activities related to the internal LSM modernization project, bringing MES and electronic batch record implementation to the site.
  • Work with the internal QA group to support documentation creation, updates, reviews, provide meeting support, and support design questions making recommendations on improvements and compliance where appropriate.
  • Support batch record traceability mapping activities in addition to other assignments as required by group management.
  • Interact with the newly designed/validated MES system and the associated documentation supporting these systems.

• External Audit:

  • Lead and/or support the planning, execution, risk mitigation, and closeout of planned external audits or assessments, including working with and coordinating contracted auditors and audit records.
  • Liaise with Supplier Quality Program stakeholders to coordinate and prioritize the completion of external audits.
  • Communicate with and monitor external supplier compliance to audits, quality agreements, and corrective actions.
  • Monitor, update, and report on external audit program metrics.
  • Travel may be up to 50% during periods throughout the year to support external auditing activities.

• Internal Audit (Self-Inspection):

  • Manage and execute the internal audit strategy and schedule with a cross-functional team, including Quality and Site leadership.
  • Lead and/or coordinate the planning, execution, risk mitigation, and closeout of internal audits.
  • Collaborate with and coach internal auditees and Quality partners for internal audit observations; ensure auditees deliver appropriate CAPAs and monitor through to closure.
  • Ensure that audit results are timely, constructively written, and formally recorded and reported with corrective and preventive actions documented appropriately.
  • Monitor, update, and report on internal audit program metrics.
  • Train, coach, and develop co-auditors and subject matter experts to support the audit program.

• Additional Responsibilities:

  • Support hosting client audits and regulatory health authority inspections.
  • Compile and provide operational and quality metrics for periodic Management review.
  • Promote a Quality Culture by driving continuous improvement, innovation, teamwork, and efficiency.
  • Perform Quality systems element assessments/audits to identify deficiencies in processes and procedures according to client quality and regulatory standards and guidance.
  • Establish core quality programs, oversight, and controls for Document Management, Change Management, Deviation/Investigation Management, and Training Management.
  • Provide expert technical and operational support for resolving quality deficiencies and remediation activities.
  • Prepare clients for audit readiness, risk management and mitigation, and review of quality procedures, documentation, and records.
  • Perform risk assessment for cGMP compliance and functional risk programs.
  • Lead and provide Quality review, certification, and management of batch records and work orders to ensure compliance with SOPs and cGMPs for lot release and disposition.
  • Participate in the development, implementation, and maintenance of the company’s quality management systems.
  • Lead investigations and activities for a variety of non-conformances which may include deviations, CAPA, OOT, AA, or OOS activities.
  • Gather information/data, prepare investigation reports, and shape corrective/preventive actions to resolve recurring problems with permanent solutions.
  • Support audit readiness and pre-approval inspection (PAI) readiness of internal and external systems.
  • Provide assistance in preparation and during regulatory inspections, due diligence audits, serving as QA escort when needed.
  • Create, review, and maintain quality records/metrics and make process improvement recommendations to management.

QUALIFICATIONS AND REQUIREMENTS:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the education, experience, skills, knowledge, and abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.

Education:

• Bachelor’s degree within a life science or related field required.

Technical Experience:

• 8-13 years of experience within Pharma/Biopharma, Medical Device, or Diagnostics industry.
• Extensive experience working with and leading Quality for various products in support of clinical/commercial manufacturing.
• Experience in the application of Quality Assurance principles, concepts, industry practices, and standards.
• Knowledge of cGMP standards, FDA regulations, US standards 21CFR210, 21CFR211, 21CFR11, 21CFR820, ICH Quality Guidelines, Quality System Regulations, and ISO standards including 13485, ISO 9001, ISO 14971.
• Significant experience with a variety of software including MS Office; Project, Visio, LIMS, and EDMS.
• Excellent communication and leadership skills as well as a strong work ethic.

Working Conditions:

• This position will be based on-site at an operational pharmaceutical facility in Raleigh, NC.
• Regular interaction with project teams, contractors, and site operations staff will be required.
• Ability to work in an open office environment with frequent distractions.
• Mon – Fri, standard work weeks and hours with occasional overtime as needed.

TOTAL REWARDS PROGRAM:

We define total rewards as compensation, benefits, remote work/flexibility, development, recognition, and our culture with programs that support each of our reward pillars. This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous flexible paid time off program, company-paid holidays, flexible working hours, and fully remote work options for most positions and the ability to work “almost anywhere”. However, if a physical work location is more for you, we have office locations in Greater Boston; San Diego, CA; Boulder, CO; and India.

COMPENSATION:

Applicants must have current work authorization when accepting a position at Sequoia. Currently, Sequoia is unable to sponsor or take over sponsorship of an employment Visa at this time.

LEGAL STATEMENT:
 
Syner-G BioPharma Group and Sequoia Biotech Consulting are proud to be an Equal Employment Opportunity and Affirmative Action employers. All employment decisions, including the recruiting, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without regard to the employee’s race, color, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, source of income, place of residence, national or ethnic origin, ancestry, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or on any other basis prohibited by applicable law. Syner-G BioPharma is an E-Verify employer.