Total 2 Director/C-Level Quality Assurance / Control job vacancies in Fort Bliss, Texas

At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers.

We foster an inclusive culture and are looking for diverse, talented people to join Alcon. As Associate Director Clinical QA, you will be trusted to provide input and assist in establishing the vision and strategic direction for Clinical R&D activities in the R&D, QA, GCP, GLP and Medical Safety Operations Groups at our Main Campus in Fort Worth, TX.

POSITION PURPOSE

• Provides input and assist in establishing the vision and strategic direction for Clinical R&D activities as part of the R&D QA GCP, GLP and Medical Safety Operations Group.
• Provides Clinical QA oversight to ensure that global Clinical Operations activities conducted by Alcon for its medical devices and pharmaceutical products are in compliance with applicable regulations, guidelines and/ or quality standards.
• Manages the Good Clinical Practice (GCP) audit program across all Alcon franchises to assure clinical related activities are conducted according to Alcon and quality standards and applicable regulations with high degree independence.  

In this role, a typical day will include:

• Provides leadership and sound business ethics in the interpretation and implementation of global GxP compliance programs, computer system and/or software validation and related services and compliance training while ensuring Clinical QA independent assessments.
• Supports clinical research and development activities for all Alcon franchises and Technology Platforms to maximize standardization and compliance.
• Advises senior management of the need for corrective and preventive actions with a key advisory role in the development of action plans and monitoring of effectiveness of action plans as a result of internal and/or external Regulatory audits.
• Ensures senior management awareness of compliance issues impacting regulatory acceptability, by appropriately escalating as per quality risk management.
• Provides support to relevant functions on proper identification and escalation of quality related issues.
• Trends, interprets and presents compliance data and metrics according to worldwide legal and regulatory requirements and Alcon standards.
• Drives/facilitates projects in collaboration with stakeholders to evaluate and or implement quality/compliance improvement initiatives.
• Leads or support cross-functional teams to evaluate impact of process changes to systems and related processes, to research best practices, determine solutions and manage change.
• Develops unique approaches to promote and instill a culture of quality and compliance.
• Provides coaching, and aid in the development of RDQA Clinical staff and business partners.
• Provides consultation and education including, but not limited to interpretation of global regulations and guidelines such as GCP, US FDA EU MDR, ISO Standards, etc.
• Authors or reviews & approves documentation including but not limited to audit schedule, plans and reports, documents associated with regulatory submissions, notes to file, study protocols, document templates, plans and reports, and clinical evaluation documents.
• Leads and supports the investigation of deviations and other quality issues detected from any source e.g., monitoring and data management, trends, signals, etc. 
• Provides guidance, review, and approval of associated deviations (NCI, CAPAs and Actions) and evaluates effectiveness.
• Provides R&D QA support to Supplier Evaluation Teams, and function as Clinical SME for service providers.
• Leads audit & inspection preparation, conduct and remediation as needed, for both national and local inspections (e.g., FDA, EMA, MHRA, TUV etc.).
• Contributes to cross-divisional activities including but not limited to FAA, FSCA and/or Market Actions/ Investigational Product Field Actions as assigned.

WHAT YOU'LL BRING TO ALCON:

• Bachelor’s Degree or Equivalent years of directly related experience (or high school +15 yrs; Assoc.+11 yrs; M.S.+4 yrs; PhD+3 yrs).
• The ability to fluently read, write, understand, and communicate in English.
• 7 Years of Relevant Experience
• 5 Years of Demonstrated Leadership
• Work hours: Exempt
• Travel Requirements: up to 20% as needed.
• Relocation assistance: No
• Sponsorship available: No

PREFERRED QUALIFICATIONS:

• Bachelor’s degree in science or technology.
• QA work experience in a regulated Medical Device / Pharmaceutical Industry.
• Strong R&D experience and knowledge, with manufacturing experience desired.
• Proven personnel management experience.
• Advanced knowledge of ISO 14155/ 14971, 13485, ICH 6, Medical Device and Pharmaceutical EU and FDA 21 CFR 820 / 211 regulatory requirements.
• Highly proficient in MS Office.
• Highly proficient in data analytics, critical thinking, and decision making.
• Proven influencing and negotiating skillset.
• Ability to lead virtual teams and function in a matrix organization, with project management experience desired.
• Advocate for exceptional Quality and Compliance Standards - does not compromise on customer expectations and regulatory requirements.

HOW YOU CAN THRIVE AT ALCON:

• Join Alcon’s mission to provide outstanding, innovative products and solutions to improve sight, improve lives, and grow your career!
• Alcon provides robust benefits package including health, life, retirement, flexible time off, and much more!

ATTENTION: Current Alcon Employee/Contingent Worker

If you are currently an active employee/contingent worker at Alcon, please click the appropriate link below to apply on the Internal Career site.

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Alcon is an Equal Opportunity Employer and participates in E-Verify. Alcon takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital or veteran status, disability, or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an email to alcon.recruitment@alcon.com and let us know the nature of your request and your contact information.

As part of the continued growth and innovation of our Air Quality technical community, ERM has an opportunity for an experienced leader to join our global consulting firm as a Partner in Baton Rouge or New Orleans, Louisiana, and become a true owner and shareholder in a business with Sustainability at its heart. 

We are looking for both established and emerging leaders who are interested in being part of this thriving global community – outstanding professionals who combine strong consulting and business development skills with a strong technical foundation – to foster and expand a network of excellent client relationships in the chemical and power industries.  We seek individuals to help us drive the continued growth of ERM’s business through selling and delivering world-class services, recruiting and developing our next generation of leaders, and further advancing our reputation for air quality and climate change solutions. 

This is a Partner-level opportunity for a Principal/Director/VP-level professional looking to further their career with an equity stake in a global environmental leader that aims to lead the field in sustainability consulting.  A career as an ERM Partner is unique. Our partnership model offers unparalleled opportunities for leaders with ambition, vision and proven expertise, providing: 

• The opportunity to contribute significantly to key decisions, including the overall strategic direction of our organization.
• Meaningful equity ownership with significant financial and intangible rewards.
• The ability to provide “thought leadership” on a wide range of technical and business issues impacting our core markets.
• An extension of ERM’s market position and reach with your established relationships to further drive our growth.

ABOUT THE SERVICE AREA:

ERM’s Air Quality technical community pursues and wins highly innovative engagements for the most interesting clients, providing the full breadth of air quality services. With annual global sales in excess of $50 million, ERM’s Air Quality service area is one of the largest among its peers in our industry and is steadily growing at a double-digit pace. In North America alone, ERM has more than 300 dedicated air quality and climate change professionals assisting clients with projects as diverse as developing responses to emerging Low Carbon Fuel Standards, to leading complex capital projects through the many hurdles associated with the NSR permitting program.

ERM is structured to encourage collaboration and networking among regional offices, providing opportunities to network with ERM’s national air quality technical team to share best practices and consulting opportunities. Our many leaders proactively work together to build strategies and campaigns around key business drivers for our clients, with the primary focus of finding and delivering high-profile rewarding projects and building our business, whether it be for GHG reporting regulations, new air dispersion modeling challenges, new MACT and NSPS standards, energy management, or climate change adaptation.

ROLE PROFILE:

• Primary focus on client account development, sales, and delivery of the full spectrum of ERM’s consulting services to deliver strategic value to our clients in the chemical and power sectors.  In particular, play a key role in growing ERM’s Air Quality business across its broad portfolio of service offerings:
  • Air quality permitting and compliance programs
  • Carbon management, energy efficiency, and climate change adaption
  • Greenhouse gas and global warming strategies
  • Atmospheric dispersion modeling
  • Air pollution control technology evaluations and compliance
  • Emission measurements and CEM systems
• Actively develop commercial strategies to pursue and win new business opportunities that result in significant revenue growth with target clients aligned with ERM’s global strategy. 
  • Provide business value selling at the top levels of client organizations, raising the profile of ERM’s capabilities within key client organizations, to identify and shape clients’ needs for ERM services.
  • Develop new client relationships and expand existing relationships by delivering strategic consulting advice, excellent value, and quality service.
  • Maintain pulse on industry business cycles and prioritize sales efforts toward high-potential, top opportunities.
  • Manage capture efforts utilizing technical understanding to develop proposals, including written content, pricing, and presentations.
• Contribute to leadership and management of major air quality programs and projects for ERM’s industrial chemical and power sector clients.  Lead consulting engagements in the areas of strategic air permitting, compliance assurance, and greenhouse gas.
• Build, grow, and manage a high-performance team, serving as a leader and mentor to consultants.  Identify emerging talent and work with them to reach their full potential; ensure rising stars are nurtured, developed and given new areas of responsibility.
• Support the growth and development of ERM’s global Air Quality service area and actively collaborate with colleagues across the globe. Drive innovation within the service area to stay ahead of client needs and to differentiate ERM in the market. 
• Work in a collaborative, cross-functional team environment to build ERM’s global business, as well as to lead client and technical teams.
• Meet business financial targets, overall project budget and schedule, client satisfaction/expectations, and internal and contract requirements.

QUALIFICATIONS:

• BS/MS in engineering or related discipline; PE preferred.
• 15+ years’ progressive air quality experience in a consulting environment, working substantially with industrial clients on Title V, PSD, NSR, BACT, MACT, GHG projects.
• Business acumen to understand business risk and challenges, and recognize corporate opportunities.
• Demonstrable track record in delivering multimillion dollar sales results annually, including successfully winning large and strategic projects.
• Offer recognized technical expertise and an established reputation in the local marketplace.

Who We Are:

As the largest global pure play sustainability consultancy, we partner with the world’s leading organizations, creating innovative solutions to sustainability challenges and unlocking commercial opportunities that meet the needs of today while preserving opportunity for future generations.

At ERM we know that creating a diverse, equitable and inclusive work environment is an essential part of making our company a great place to build a career. We also see our diversity as a strength that helps us create better solutions for our clients. Our diverse team of world-class experts supports clients across the breadth of their organizations to operationalize sustainability, underpinned by our deep technical expertise in addressing their environmental, health, safety, risk and social issues. We call this capability our “boots to boardroom” approach for its comprehensive service model that allows ERM to develop strategic and technical solutions that advance objectives on the ground or at the executive level.

Please submit your resume and brief cover letter. 

ERM does not accept recruiting agency resumes. Please do not forward resumes to our jobs alias, ERM employees or any other company location. ERM is not responsible for any fees related to unsolicited resumes.

ERM is proud to be an Equal Employment Opportunity employer. We do not discriminate based upon race, religion, color, national origin, gender, sexual orientation, gender identity, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. 

Thank you for your interest in ERM!